Global & Disaster Medicine

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Summary of Process for Emergency Use Authorization (EUA) Issuance

The flow chart below provides a summary of the process for Emergency Use Authorization (EUA) issuance.

Flow chart providing a summary of the process for Emergency Use Authorization (EUA)

 

Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

  1. The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency
  2. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.
  3. The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency
  4. The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA.  This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met.  FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.


Current Emergency Use Authorizations

Emergency Use Authorization, with Emergency sign

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

Current EUAs

The tables below provide information on current EUAs:


How FDA helps make MCMs (medical countermeasures) available in emergencies

How FDA helps make MCMs available in emergencies
The first in an occasional series on the ways FDA helps prepare for and respond to public health emergencies
During public health emergencies, medical countermeasures (MCMs) may be needed to prevent or treat diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents or emerging infectious diseases, like pandemic influenza or Ebola.
Depending on the emergency and public health need, MCMs may be provided by the Strategic National Stockpile (managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR), in the U.S. Department of Health and Human Services (HHS)), or through state and local stockpiles or other supplies. When needed during a public health emergency, MCMs are usually dispensed or administered to impacted individuals by healthcare workers and public health responders under official federal, state, and local emergency response plans.
In some cases, MCMs might already be approved and will be used in approved ways during a response. In other cases, the best medical products available for a response might be unapproved or need to be used in unapproved ways. Because of our role in regulating medical products, FDA may need to use special authorities to allow the use of such MCMs in impacted populations during or in anticipation of emergencies.
 
Mechanisms FDA can use to allow the emergency use of MCMs include the Emergency Use Authorization (EUA) authority and several authorities related to the emergency use of approved MCMs.

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

For Immediate Release

November 9, 2018

Release

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated.

The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD.

“The scourge of Ebola tragically demonstrates that we’re a global community when it comes to public health protection. Infectious disease doesn’t recognize nation states. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, our FDA team of experts in drugs, vaccines and diagnostics continue to collaborate with our Federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak in the Democratic Republic of Congo,” said FDA Commissioner Scott Gottlieb, M.D. “This EUA is part of the agency’s ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible. We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

The FDA’s EUA authority allows the agency to authorize the use of an unapproved medical product, or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved and available alternatives. When circumstances exist justifying authorization, the EUA becomes an important mechanism that allows broader access to medical products that have not been FDA cleared or approved and are instead only authorized for use for the duration of an emergency declaration. The FDA’s criteria for issuing an EUA for a diagnostic test includes making an assessment that it is reasonable to believe, based on the totality of evidence available to the agency, that the test may be effective and the known and potential benefits of using the test outweigh its known and potential risks.

In 2014, during the Ebola outbreak in West Africa, an emergency was declared by the Secretary of Health and Human Services. While that outbreak has ended, ongoing, smaller Ebola outbreaks have continued, and the emergency declaration is still in place. Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks.

The DPP Ebola Antigen System provides rapid diagnostic results with tests that can be performed in locations where a healthcare provider does not have access to authorized Ebola virus nucleic acid tests (PCR testing), which are highly sensitive but can only be performed in certain laboratory settings that are adequately equipped. The DPP Ebola Antigen System has been authorized for use with capillary “fingerstick” whole blood, ethylenediaminetetraacetic acid (EDTA, an anticoagulant added to whole blood to prevent coagulation) venous whole blood and EDTA plasma. The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing.

While today’s action will increase access to diagnostic tools for healthcare providers who may not have otherwise been equipped to perform tests, it is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus.

The FDA remains committed to using its authorities and resources to advance the development of countermeasures to address emerging threats and recently outlined its efforts to help address Ebola virus outbreaks. The FDA will continue to work with its federal partners and potential commercial product manufacturers in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola virus disease for emergency use during this and any future outbreak.

With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA

September 5, 2018

Statement

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

We’ve established a framework to help assure that drug products all meet the same high-quality standards, regardless of where they’re manufactured; and whether they’re brand name or generic products, or prescription or over-the-counter drugs. Today, we’re announcing several steps that improve on that effort.

Helping assure the quality and safety of globally produced products requires a variety of efforts at different times throughout the lifecycle of a drug’s manufacturing and finishing. Our inspections and surveillance of manufacturing facilities are an integral part of this oversight. We need to make sure that our inspections are prioritized based on potential risks to patients, and that we’re using our resources efficiently.

Today, to add greater transparency around our site selection model, we’re publishing our internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections. Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.

The FDA prioritizes inspections of sites regardless of their location. For manufacturing facilities in other countries, inspections may be conducted by staff in foreign offices, those on temporary duty assignments, or staff that travel internationally to conduct the inspection. In addition, to maximize resources and efficiency, we’ve also pursued opportunities to collaborate with other countries. With our announcement last year concerning the Mutual Recognition Agreement with the EU, we’ve ensured that we can recognize the drug inspections conducted by foreign regulatory authorities that meet U.S. requirements. In doing so, we’re able to dedicate more of our investigators’ time to those sites that pose the greatest risk.

The FDA’s inspections program is a large-scale endeavor. As of Fiscal Year 2017, there were about 5,063 human pharmaceutical sites worldwide subject to routine surveillance inspection – 3,025 of those were foreign-based. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 on foreign soil, to ensure manufacturers were following Current Good Manufacturing Practice (CGMP) requirements and maintaining high quality standards. To accomplish this critical work, we need to maximize our resources around the globe, which is why the FDA uses a risk-based site selection model to ensure that inspectional resources are allocated in the most efficient and appropriate manner to protect patient health. The risk-based site selection model is structured so that the inspection frequency for all facilities, regardless of where the facility is located, prioritizes our inspections of sites where the drug being produced and the manufacturing processes used pose the greatest potential risk for problems that could harm patients.

In addition to identifying the facilities of greatest risk and prioritizing those inspections, the FDA has also made efforts to ensure our resources are effectively deployed to address inspection demands. Last year, for example, we modernized the structure of our field organization, including inspection operations, to direct our focus and organization around the types of programs we regulate. Previously, we had organized our field activities and resources based on geographic regions. The new structure, which focuses resources based on areas of specialization, allows us to better align the expertise of our staff with our commitments.

But it’s important to note that inspections are not the only way we work to ensure product quality. For example, we provide guidance documents on a range of quality issues, from pharmaceutical development through commercial manufacturing and quality control, on original application submissions and on making changes after approval, addressing active ingredients and finished product. We also obtain drug samples and test drugs from various sources each year to evaluate aspects of quality that can be analytically measured and verified. It’s also important that we’re transparent about inspection outcomes.

Following each inspection, the FDA assesses the significance of the findings leading to a final classification into one of three categories – no action indicated, which means the agency found no objectionable conditions during the inspection; voluntary action indicated, which means the agency found objectionable conditions, but we are not recommending regulatory action at this time; or official action indicated, which means the agency found objectionable conditions and may pursue regulatory action.

The agency recently updated its inspections classifications database, which provides the most recent classifications of inspections of manufacturing facilities conducted for routine CGMP surveillance purposes or inspections of sites conducting bioequivalence/bioavailability studies. The database provides transparency to the industry, the general public, and other regulators into the outcomes of recent observations. The database has also been updated to build on our progress implementing the Mutual Recognition Agreement with the European Union, and now supports inclusion of facility status based on classification of inspection reports from recognized foreign regulatory authorities.

FDA carried out these updates well ahead of our scheduled commitment under the reauthorized Generic Drug User Fee Amendments (GDUFA II) to perform the updates by 2019. The agency went beyond the commitment to provide timely updates regarding generic drug manufacturing facilities – as the database is updated every 30 days with classifications for inspections for all FDA regulated products, not just generic drugs. While we take effort to ensure transparency, it’s important to note that the numbers from our database don’t account for all of the inspections that the FDA conducts at any given time. These are a subset of inspections that have received a final classification. We classify inspections on a rolling basis after taking a thorough look at all the relevant information available. So there’s a lag between the performance of an inspection and the final classification. Communicating information from inspections in a timely way is a priority. We are continually seeking to refine this process.

Ensuring quality standards are met

When objectionable conditions are identified with manufacturing processes or controls, creating a risk of potentially producing an unsafe product, it’s important that the problems are quickly remedied.

What we find is that the majority of firms – both in the U.S. and overseas – are operating within the standards U.S. patients deserve and that meet our standards. When needed though, we exercise our regulatory authority commensurate with the assessed risk, including issuing import alerts, warning letters, and in the most serious cases, working with firms as they recall drugs, seizing drugs in commerce or enjoining manufacturers to prevent further violations. We will continue to remain vigilant in our compliance and enforcement work, and we’ve taken a number of actions already this year.

We’ve enhanced our communications about inspections to facility owners to enable quicker resolution of situations where quality standards are not being met. For example, efficiencies from a Concept of Operations agreement the FDA implemented last year have enabled us to communicate inspection classification information to facility owners within 90 days of the close of a surveillance inspection, a significant improvement from past timelines. We’ve also established procedures to notify applicants when we identify issues during our premarket inspections that could impact approvability of a new drug application by communicating through an information request, discipline review letter or complete response letter. By discovering issues before the production process commences, we’re able to assist companies to circumvent future issues before they occur and help get quality products to patients more efficiently.

Harmonization and fostering technological advancements

In addition to these efforts, cooperation and harmonization with other foreign regulators are critical to ensuring that the drug supply produced outside the U.S. meets our safety and efficacy standards. To advance these goals, we participate in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which focuses on harmonizing how inspections are conducted. We also participate in the International Council for Harmonisation (ICH), which is a global body established to facilitate international collaboration that’s been successful in standardizing and elevating drug development practices and quality standards throughout the world. The goal is to ensure companies maintain a level of quality throughout the product lifecycle.

Having the same standards across multiple regulatory agencies makes it easier for manufacturers to ensure compliance with quality standards. This approach reduces the burden from having to implement different sets of requirements. This is also an important role of our foreign offices – to establish relationships with foreign regulators and to build our intelligence regarding these markets so we can target higher risk firms.

We’re also committed to fostering more advanced manufacturing practices, such as continuous manufacturing, that encompass advanced manufacturing technologies, implemented in a way that leads to more innovative, consistent and dependable manufacturing of drug and biological products. These technologies have the potential to help establish more reliable supply of drug and biological products by reducing manufacturing failures that can cause supply disruptions and drug shortages. Just this month, we awarded grants to three research institutions in efforts to adopt this pioneering technology more widely. We’ll continue to advance efforts to support the effective utilization of these new platforms.

We’ll continue to take new steps to address the challenges posed by a globalized drug supply chain. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products sold in the U.S. regardless of where a drug is manufactured.


FDA issues final guidance for drug companies to use for developing pre-exposure prophylaxis for inhalational anthrax.

FDA

FDA In Brief: As part of a longstanding program encouraging the development of medical countermeasures; new FDA policy promotes innovation to thwart inhalational anthrax

May 23, 2018

Media Inquiries

  Tara Rabin
  240-402-3157

“The FDA has long played an important role preparing our nation for potential bioterrorism threats, providing guidance and support around the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said FDA Commissioner Scott Gottlieb, M.D. “Since the 2001 anthrax attacks, the U.S. government’s efforts to protect the nation from bioterrorism threats have continued to evolve. We now know that a comprehensive preparedness plan for potential anthrax threats must account for both pre- and post-exposure scenarios. That’s why the FDA has taken steps to modernize its guidance on inhalational anthrax to advance the development of new drugs for prophylaxis, prior to exposure. This builds upon the treatments that are currently available for inhalational anthrax and advances the agency’s longstanding commitment to the development of a full suite of medical countermeasures as part of its established programs.”

The U.S. Food and Drug Administration today issued final guidance, Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax, which is designed to assist in the development of drugs for prophylaxis (prevention) of inhalational anthrax for individuals who may be potentially exposed to or have inhaled aerosolized Bacillus anthracis (B. anthracis) spores, but who have not yet displayed related signs and symptoms.

While there are FDA-approved drugs for treatment of anthrax and for post-exposure prophylaxis of inhalational anthrax, situations can arise where starting therapy immediately before the anticipated or potential exposure can reduce the risk of illness and death (for example, first responders who anticipate an imminent risk of exposure to B. anthracis spores).

The FDA’s final guidance is the result of a multi-year effort to advance its policy framework for the development of treatments targeting inhalational anthrax. The final guidance revises the indication to “prophylaxis of inhalational anthrax” for the reduction of disease risk in those who have inhaled, or are likely to inhale, aerosolized B. anthracis spores, but who do not yet have established disease.

Clinical trials in humans cannot be conducted since naturally occurring inhalational anthrax is extremely rare and it would be unethical to deliberately expose healthy human volunteers to B. anthracis spores. Therefore, the final guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax can rely on evidence from animal studies (known as the Animal Rule) to support approval when the criteria under the Animal Rule have been met.

The FDA encourages drug developers to reference the final guidance issued today when designing studies to appropriately establish the safety and effectiveness of drugs for prophylaxis of inhalational anthrax.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


FDA: Information about E. coli O157:H7 Outbreak Likely Linked to Leafy Greens

FDA

January 10, 2018

The U.S. Food and Drug Administration is working with the Centers for Disease Control and Prevention (CDC), and state and local authorities in an investigation of an outbreak of Shiga toxin-producing Escherichia coli (E. coli) O157:H7 illnesses. The FDA has also been in contact with Canadian food safety authorities on this outbreak, since cases were first identified in Canadadisclaimer icon

Whole genome sequencing showed that the U.S. and Canadian E. coli O157:H7 strains are closely related, suggesting a common source of illness. Canadian health officials identified romaine lettuce as the likely source of their outbreak. CDC has been working to determine the source of the outbreak in the U.S., and today announced it believes that this outbreak is likely linked to leafy greens. Health officials have not identified a specific type of leafy greens that sick people ate in common.

The known illnesses in the U.S. had illness onsets in late November and early December. This suggests that suspect leafy greens linked to this outbreak are likely no longer in the food supply.

The FDA’s outbreak investigation team is working with CDC and state and local officials to determine what ill people ate, where they bought it, and the distribution chain — all with the goal of reaching where these foods were produced, to see if there’s any common food or point where the food might have become contaminated. At this point, we have not identified a common or single point of origin for the food that made people ill. We want to make sure the information we provide is accurate and when we have information that consumers can use – such as any foods to avoid – we will share it immediately.


FDA: Tips about Medical Devices and Hurricane Disasters

FDA Offers Tips about Medical Devices and Hurricane Disasters

General Safety

  • Keep your device and supplies clean and dry.
  • If you depend on your device to keep you alive, seek emergency services immediately. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
  • Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
  • If your device appears to be damaged, or if you need a back-up device, contact your distributor or device manufacturer.
  • Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.
  • Maintain your device only in a well lit area so you can assess your device’s performance (e.g., refilling your insulin pump, checking your glucose meter).
  • Keep your device in as clean and secure location as possible: off the ground, away from animals or crowded areas.
  • Always check your device for pests before you use it (e.g., syringes, mechanical devices).

 


Power Outage

  • Notify your electric company and fire department to let them know you have a medical device that needs power (e.g., ventilator, apnea monitor).
  • Read your user instructions or call your distributor or device manufacturer to find out if your device can be used with batteries or a generator.
  • Locate a generator if possible.
  • Make sure you check for water before plugging in your device. Do not plug in a power cord if the cord or the device is wet.
  • When the power is restored, check to make sure the settings on your medical device have not changed (often medical devices reset to a default mode when power is interrupted).

 


Warning about Potential Carbon Monoxide Problems when Using Generators

Since many medical devices used in the home require a source of electrical power, generators are often used to supply electricity during a general power outage. The following points should be followed to prevent carbon monoxide poisoning.

  • Never run a generator, pressure washer, or any gasoline-powered engine inside a basement, garage, or other enclosed structure, even if the doors or windows are open, unless the equipment is professionally installed and vented.
  • Never run a motor vehicle, generator, pressure washer, or any gasoline-powered engine outside an open window or door where exhaust can vent into an enclosed area.

 


Water Contamination

Some medical devices and equipment, such as dialyzers or IV pumps, require safe water in their use, cleaning, and maintenance.

Hurricanes, especially if accompanied by a tidal surge or flooding, can contaminate the public water supply. In the area hit by a hurricane, water treatment plants may not be operating; even if they are, storm damage and flooding can contaminate water lines.

Listen to and follow public announcements about the safety of the municipal water supply.

In an emergency situation, follow these steps to ensure that your water is safe for use with your medical device:

  • Use only bottled, boiled, or treated water until your supply is tested and found safe.
  • If you use bottled water, be sure it came from a safe source. If you do not know that the water came from a safe source, you should boil or treat it before you use it.
  • Boiling water, when practical, is the preferred way to kill harmful bacteria and parasites. Bringing water to a rolling boil for 1 minute will kill most organisms.
  • When boiling water is not practical, you can treat water with chlorine tablets, iodine tablets, or unscented household chlorine bleach (5.25% sodium hypochlorite). If you use chlorine tablets or iodine tablets, follow the directions that come with the packaging.
  • If you use household chlorine bleach, add 1/8 teaspoon (~0.75 mL) of bleach per gallon of water if the water is clear. For cloudy water, add 1/4 teaspoon (~1.50 mL) of bleach per gallon. Mix the solution thoroughly and let it stand for about 30 minutes before using it.

Note: Treating water with chlorine tablets, iodine tablets, or liquid bleach will not kill parasitic organisms.

Use a bleach solution to rinse water containers before reusing them. Use water storage tanks and other types of containers with caution. For example, fire truck storage tanks and previously used cans or bottles may be contaminated with microbes or chemicals.

For additional information on keeping water safe, see http://www.bt.cdc.gov/disasters/foodwater.asp.

 


Sterility

  • When performing medical procedures, maintain a clean environment by using bleach, alcohol, or a disinfectant in the area you are working (e.g., catheter changes, dressing changes, suctioning).
  • Check sterile packaging to make sure it is dry and intact (e.g., sterile gauze). If the packaging is wet or damaged, do not use the product inside.
  • When you purchase supplies, always check the packaging to make sure it hasn’t been damaged.

 


Re-use of Medical Devices

Do not reuse a medical device intended for single use.

If you find that you need additional single use products, contact a healthcare provider or emergency response personnel.

  • If you need to reuse a device that is intended for multiple uses (e.g., infusion tubing, syringes), the device must be cleaned and disinfected or sterilized according to the device manufacturer’s instructions. Devices should not be boiled unless explicitly allowed on the product label or instructions for use.
  • If you have supplies that are intended for multiple use with your medical device, follow the appropriate procedures for cleaning and disinfecting.
  • If you need sterile water for cleaning, disinfecting, or sterilizing your device or its components, follow the above procedures for ensuring that your water is safe.

 


Dealing with Heat and Humidity

Heat and humidity can have an effect on home diagnostic test kits (including blood glucose tests used by people with diabetes). Test results may not be accurate. Read your owner’s manual to make sure your test kit is performing properly.

Special Information about Using Blood Glucose Meters

Heat and humidity can damage blood glucose meters and test strips.

If you use a blood glucose meter, check the meter and test strip package insert for information on use during unusual heat and humidity. Store and handle the meter and test strips according to the instructions. Perform quality-control checks to make sure that your home glucose testing is accurate and reliable.

To protect your device from heat and humidity, follow the steps below:

  • Use a dry cloth to wipe off your device regularly (e.g., mechanical infusion pumps).
  • Keep your device out of direct sunlight.
  • Enclose your medical products in plastic containers to keep them dry (e.g., wound care supplies).
  • Do not use ice if there is a danger of water contamination; use dry ice or instant cold packs to keep your device cool (e.g., prefilled syringes).
  • Do not use disposable devices that are wet (e.g., wound dressings, disposable thermometers, tubing).


FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus

FDA

Scientists at the U.S. Food and Drug Administration (FDA) have developed an assay that assesses the ability of antibodies to neutralize Ebola virus, using a technique that does not require the use of Ebola virus itself and can be automated for rapid testing of large numbers of samples.

The new FDA assay is important because the effectiveness of most licensed viral vaccines is based on their ability to trigger production of neutralizing antibodies. Therefore, methods for assessing neutralization activity of antibodies will likely be an important component for evaluating the effectiveness of Ebola virus vaccines and identifying correlates of protection (measurable signs of immunity).

The assay is based on a widely used technique called micro-neutralization, which measures the ability of antibodies to prevent viruses from infecting animal cells and reproducing themselves. The greater the neutralization of a virus by antibodies, the fewer the number of viruses are able to infect cells and the less the viruses can replicate themselves by making copies of viral genetic material.

A key attribute of the assay is built upon the use of a genetically modified, non-disease-causing virus called vesicular stomatitis virus (VSV). The modified VSV carries part of the genome from Ebola virus and can substitute for Ebola virus in certain assays—an approach previously used at FDA.

The use of genetically engineered VSV eliminates the need for additional precautions, like a BSL-4 laboratory, because the modified virus is incapable of causing Ebola disease. These laboratories are designed for working with pathogens that pose a high risk of life-threatening disease through aerosol transmission and for which there is no vaccine or treatment. The FDA assay is appropriate for BSL-2 laboratories, which are widely available and do not require the more elaborate containment requirements of BSL-4. The need for BSL-4 laboratories for scientists to work with Ebola virus has complicated the worldwide effort to study the virus and develop and assess the effectiveness of Ebola virus vaccines.

The FDA scientists genetically modified different versions of VSV, so each one carried on its surface one of four variations of a molecule called an envelope glycoprotein (GP) found on different strains of the Ebola virus. Then they used a technique called quantitative polymerase chain reaction to measure the amount of genetic material produced by the hybrid VSV after it had been exposed to commercially available antibodies to Ebola virus. Automating the process should offer an important time advantage to public health scientists during investigations of an outbreak. The assay can determine within 6 to 16 hours if antibodies are effective against the Ebola virus.

The scientists showed that the assay was able to assess whether specific antibodies targeting each GP neutralized the different hybrid VSV variants, preventing the virus from infecting the cells and multiplying. Moreover, the results of the Ebola antibody assays agreed with those obtained by other, more complex assays, now used for such testing. This suggests that the assay will be useful in evaluating the ability of antibodies, triggered either by vaccines or natural infection, to neutralize specific varieties of the virus. Moreover, it might be possible to adapt the assay to assess neutralizing antibodies against other viral pathogens.

 

Title

Development of a micro-neutralization assay for ebolaviruses using a replication-competent vesicular stomatitis hybrid virus and a quantitative PCR readout

Vaccine 17 April 2017

DOI: 10.1016/j.vaccine.2017.03.019disclaimer icon

Authors

Stella S. Lee, Kathryn Phy, Keith Peden ⇑, Li Sheng-Fowler

Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States

⇑ Corresponding author at: Building 52/72, Room 1220, CBER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
E-mail address: keith.peden@fda.hhs.gov (K. Peden).

 


FDA approves field trial on the release of Oxitec’s genetically engineered (GE) mosquitoes (OX513A) to suppress the local Aedes aegypti mosquito population

FDA

Update

August 5, 2016

The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.

FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.


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