FDA Policy/General

Latest Federal Register Notices

Putney ANDA for Mupirocin Ointment Approval Withdrawn
Federal Register notification of withdrawal: FDA has at the sponsor’s request withdrawn approval of a Putney, Inc. ANDA for mupirocin ointment 2% because the product is no longer manufactured or marketed. To view the notice, click here.

20 New Animal Drug Approvals Withdrawn
Federal Register notification of withdrawal. FDA has withdrawn approval of 18 new animal drug applications and two abbreviated new animal drug applications. The withdrawals involve antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed, and they are no longer manufactured or marketed. Additionally, the products were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209.” To view the notice, click here.

Docket Established for Pediatric Postmarketing Reviews
Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between 9/17/2016 and 2/24/2017 on the agency’s Web site, but will not be presented at a 3/6-7 Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public. To view the reviews, click here. To view the notice, click here.

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