FDA Policy/General

Latest Federal Register Notices

Joint Panel to Review Pfizer Osteoarthritis BLA
Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees. Panel members are scheduled to discuss a Pfizer BLA for tanezumab subcutaneous injection, indicated for relieving signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. To view the notice, click here. 2/12/2021

Final Guide Revised on Convalescent Plasma
FDA has issued a revised final guidance entitled “Investigational Covid-19 Convalescent Plasma.” The agency has revised the recommendations in the guidance addressing convalescent plasma donors. The revisions discuss when individuals who have received an investigational Covid-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed Covid-19 monoclonal antibody therapy, qualify as convalescent plasma donors. It also revises the recommendations in the guidance pertaining to the qualification and labeling of high titer Covid-19 convalescent plasma under an EUA. 2/12/2021

Info Collection Revision on New Drug Applications
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Application for FDA Approval To Market a New Drug” (OMB Control No. 0910-0001). The revision pertains to provisions established through the agency’s user fee programs, most recently authorized under the FDA Reauthorization Act of 2017. These provisions relate to review transparency, communications with FDA, dispute resolution, drug safety enhancements, and agency resource allocation to align with program objectives agreed upon during user fee negotiations (e.g., “Performance Goals for Fiscal Years 2018-2022” Commitment Letters). To view the notice, click here. 2/12/2021

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