FDA Policy/General

FDA 6-Month PREPP Initiative Report

FDA has issued a report, FDA Covid-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report, summarizing the insights, supporting facts, and work of the FDA Covid-19 PREPP initiative between 7/2020 and 12/2020. The report describes ongoing and potential prospective actions to strengthen the agency’s Covid-19 response and build the agency’s resilience to respond to future emergencies. It does not offer a retrospective assessment of FDA’s Covid-19 response, it says.

According to the report, PREPP has been focused on identifying options for, and selectively progressing, prospective enterprise-wide response and resilience actions, including programmatic, process, and organizational initiatives.

FDA actions cited in the report include:

publishing more than 65 guidances relating to Covid-19;
reviewing over 2,300 emergency use authorization requests and issuing over 600 emergency use authorizations;
reviewing and conducting inspection activities for nearly 400 Covid-19 therapeutic candidates; and
issuing over 150 Warning Letters to companies to enforce the safety and quality of Covid-19 related products and preventing or removing more than 1,200 fraudulent Covid-19 products from the market.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome