Drugs

PDUFA 8 Commitment Letter Analyzed

Three Akin Gump attorneys say the PDUFA 8 commitment letter released by FDA earlier this month details performance goals and procedures across six areas of focus: (1) ensuring the effectiveness of the human drug review program; (2) continued enhancement of user fee resource management; (3) transparency in FDA hiring and retention of drug review staff; (4) information technology goals; (5) improving agency performance management; and (6) progress reporting for PDUFA 8 and continuing PDUFA 7 initiatives.

The analysis lists these highlights from the letter:

assessment of the program;
pivotal protocol prioritization;
meeting management goals;
expediting drug development and enhancing the use of regulatory science tools;
enhancement and modernization of the FDA drug safety system;
advancing chemistry, manufacturing, and controls facility assessment;
supporting review of allergenic extract products;
continued enhancement of user fee resource management;
enhancements to fee mechanisms; and
impact of PDUFA 8 enhancements on user fee revenue.

It also contains a chart showing deliverables and timelines from the letter.

FDA is receiving comments on the letter and has scheduled a 9/16 public meeting to receive comments.

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