|
The latest from FDA
Antimicrobial resistance update
FDA approves first orally administered fecal microbiota product for the prevention of recurrence of Clostridioides difficile infection
|
FDA approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI. Caused by the bacterium C. difficile, CDI is one of the most common healthcare-associated infections in the United States and is associated with 15,000 to 30,000 deaths annually. (April 26, 2023)
Related: Antimicrobial Resistance Information from FDA
|
|
 |
COVID-19 vaccine updates
Pfizer-BioNTech COVID-19 Vaccine, Bivalent
FDA authorized (PDF) the following uses of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age with certain types of immunocompromise who have previously received three 0.2 mL doses (Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent):
- a fourth dose administered at least 1 month following the most recent dose;
- additional doses that may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.
FDA also revised the fact sheets for Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to reflect these changes. (April 28, 2023)
|
|
|
Emergency Use Authorization (EUA) updates
New COVID-19 at-home test EUA
FDA issued an EUA (PDF) for the Status COVID-19 Antigen Rapid Test for Home Use (manufactured by Princeton BioMeditech Corp.), an over-the-counter COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used for serial testing for people who have symptoms within the first 5 days of symptoms or for people who do not have symptoms. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH.
The test should always be repeated if a negative result is found. Specifically,
- test at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or
- test at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms.
The test can be used for people age 14 years or older with a self-collected nasal swab sample, or age 2 years or older when an adult collects the nasal swab sample. (April 24, 2023)
COVID-19 in vitro diagnostic (test) EUAs
As of May 2, 2023, 446 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 62 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 29 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 47 antigen tests and 7 molecular tests for serial screening programs. FDA has also authorized 1,358 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
|
|
|
Events
-
New! May 4, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials will testify at a U.S. Senate Committee on Health, Education, Labor & Pensions hearing, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act (1:00 p.m. ET)
-
May 4, 2023: Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance (1:00 - 3:00 p.m. ET) - For patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance.
-
May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual)
-
May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual)
-
New! June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Please register in advance.
-
June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual)
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
|
|
Information for industry and health care providers
ICYMI: New draft guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
FDA announced availability of a draft guidance for industry, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Submit comments by July 19, 2023. (April 19, 2023)
Shelf life extension reminder: COVID-19 therapeutics
For a searchable and downloadable table listing the original expiration dates and, if applicable, extended expiration dates for the following COVID-19 therapeutic products: bamlanivimab, bebtelovimab, etesevimab, Evusheld, Lagevrio (molnupiravir), REGEN-COV, and sotrovimab, see from HHS/ASPR: COVID-19 Therapeutic Product Expiration Dates. Paxlovid (nirmatrelvir co-packaged with ritonavir) expiry data is available from the manufacturer's website. For more information about shelf life extension, see Expiration Dating Extension. For more information about COVID-19 therapeutics, see Coronavirus (COVID-19) Drugs.
Letter to health care providers on cybersecurity
FDA issued a Letter to Health Care Providers to inform health care providers and laboratory personnel about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments.
These instruments may be specified either for clinical diagnostic use in sequencing a person’s DNA for various genetic conditions or for research use only (RUO). At this time, the FDA and Illumina have not received any reports indicating this vulnerability has been exploited. (April 27, 2023)
FDA takes additional steps to advance decentralized clinical trials
FDA is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. On May 2, 2023, the agency released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant’s home using telemedicine. Submit comments on the draft guidance by August 1, 2023. Also see: CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies
In March 2023, FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. Learn more
|
|
In case you missed it
Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine is available near you.
|
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 400 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
