Drugs

PMR/PMC Annual Statistical Report

The FY 2021 Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments shows that as of 9/30/21 there were 373 unique applicants with open postmarketing requirements (PMR)/postmarketing commitments (PMC) and 808 unique open applications. The report also shows that 79% of NDA and BLA annual status reports were received on time.

As of 9/30/21, 69% of open NDA and BLA PMRs were progressing on schedule, as were 76% of NDA and BLA PMCs.

FDA is pleased to report that applicants completed (fulfilled) or released most of the PMRs/PMCs for the previous years reported on in the FY2021 report, the agency says. It says the majority of PMRs/PMCs are progressing according to the original schedule. Overall, very few PMRs/PMCs are delayed, according to FDA.

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