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Editor’s note: FDA has launched the FDA Roundup on Tuesday and Friday to highlight the FDA’s activities across the agency. The Office of Global Policy and Strategy will be forwarding the Roundup to our international colleagues on a regular basis.
FDA Roundup: January 11, 2022
Dear International Colleague,
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Jan. 10, the FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension), provided that the claims are appropriately worded to avoid misleading consumers and other factors for the use of the claim are met.
- Today, Acting FDA Commissioner Janet Woodcock, M.D., testified before the U.S. Senate Committee on Health, Education, Labor and Pensions in a hearing titled, Addressing New Variants: A Federal Perspective on the COVID-19 Response. Her congressional testimony can be found here.
- Today, the FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers. These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine. Specifically, the Fact Sheet for Health Care Providers includes information about reports of adverse events following use of the vaccine which suggest an increased risk of ITP during the 42 days following vaccination, and that individuals with a history of ITP should discuss the risk and the potential need for platelet monitoring following vaccination with their healthcare provider. The Fact Sheet for Recipients and Caregivers includes additional information under the questions, “What should you mention to your vaccination provider before you get the Janssen COVID-19 Vaccine?” and “What are the risks of the Janssen COVID-19 Vaccine?” regarding ITP, as well as what to look for and when to seek medical attention. The FDA and CDC continue to monitor the level of potential excess risk. Individuals should speak to their health care provider to determine which COVID-19 vaccine is most appropriate for their own situation.
- COVID-19 testing updates:
- As of today, 420 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 43 antigen tests. There are 69 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 756 revisions to EUA authorizations.
Additional Resources:
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