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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- April 18, 2023: FDA Roundup including a CDER Conversation about the center's important work in enhancing regulatory science research
- April 18, 2023: FDA held a webinar: Guidances on COVID-19 Transition Plans for Medical Devices (meeting materials will be posted)
- April 18, 2023: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines
- April 14, 2023: HHS Fact Sheet: HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19
- April 14, 2023: FDA Roundup including a safety communication recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators by O&M Halyard and to use caution with certain surgical masks and pediatric face masks by O&M Halyard
- April 13, 2023: Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19 (updated)
- April 12, 2023: Safely Using Hand Sanitizer (updated)
- April 11, 2023: FDA Roundup including an upcoming virtual public meeting on May 10-11, Considerations for Buprenorphine Initiation and Maintenance Care
- April 7, 2023: FDA Roundup including a recall notice about Philips Respironics Recall Certain Reworked DreamStations CPAP, BiPAP machines for the risk they may deliver inaccurate or insufficient therapy
- April 6, 2023: Draft guidance: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act
- April 5, 2023: Draft guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
Quick links: COVID-19 updates from FDA, FDA Mpox Response
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COVID-19 vaccine updates
FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines
FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. (April 18, 2023)
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Emergency Use Authorization (EUA) updates
FDA issues EUA for new COVID-19 over-the-counter at-home antigen test
FDA issued an EUA (PDF) for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech, Inc.). 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 can be used for serial testing for symptomatic people within the first 6 days of symptom onset or for people who do not have symptoms and shows results in 15 minutes. This test should always be repeated if a negative result is found - at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or 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 aged 14 years or older with a self-collected nasal swab sample and aged 2 years or older when an adult collects the nasal swab sample. (April 14, 2023)
EUA revocations
FDA revoked these EUAs for the reasons noted in the revocation letters (PDFs):
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
COVID-19 in vitro diagnostic (test) EUAs
As of April 18, 2023, 446 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 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, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 46 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,349 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.
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April 25-26, 2023: FDA - United States Pharmacopeia (USP) Asia-Pacific Economic Cooperation (APEC) Medical Product Supply Chain Dialogue (Rockville, MD or webcast) - To bring international medical product regulators, multilateral organization representatives, and industry and academic professionals together, to discuss public health priorities, the impact of the COVID-19 pandemic on supply chains, and why the APEC Supply Chain Security Toolkit (PDF) continues to be a valuable tool to stakeholders.
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New! April 26, 2023: Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency (12:05 - 1:00 p.m. ET) - FDA will host a virtual town hall for COVID-19 test developers to discuss the two final COVID-19 transition guidances.
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New! 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.
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May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual) - To provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Seating is limited to approximately 250 attendees and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early.
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New! May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
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June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
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Information for industry and health care providers
FDA issues guidance to assist applicants and manufacturers with notifying FDA of a permanent discontinuance or interruption in manufacturing of finish products and APIs
FDA announced the availability of a draft guidance to help prevent and mitigate drug shortages: Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act. The purpose of this guidance is to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain APIs that may, in turn, help the agency in its efforts to prevent and mitigate drug shortages.
While some supply disruptions and product shortages cannot be predicted or prevented, early communication and detailed notifications to FDA from manufacturers play a significant role in decreasing the incidence, impact, and duration of supply disruptions and product shortages. These notifications allow the agency to evaluate the situation and determine an appropriate course of action. Submit comments by June 5, 2023. (April 6, 2023)
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
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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 booster dose is available near you.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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FDA Medical Countermeasures Initiative (MCMi) News)
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