Wednesday, 12 January 2022

• Yesterday, Acting FDA Commissioner Janet Woodcock, M.D., testified before the U.S. Senate HELP Committee in a hearing titled, “Addressing New Variants: A Federal Perspective on the COVID-19 Response.”  The U.S. Food and Drug Administration (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), and 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.  Last week, FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.  FDA recently issued warning letters to Varigard, LLC and to Amcyte Pharma, Inc. for selling unapproved products with fraudulent COVID-19 claims. (Authored by Randy Prebula)

• On 22 December 2021, FDA published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the COVID-19 public health emergency to increase availability of medical devices. The first draft guidance covers the transition plan for medical devices that were issued emergency use authorizations (EUAs) during the pandemic; and the second draft guidance applies to devices falling within the scope of FDA’s temporary enforcement discretion policies that will end as businesses return to normal operations. We have analyzed these documents in depth online here, and FDA will accept comments on the guidance documents until 23 March 2022. (Authored by Lina Kontos and Blake Wilson)