Drugs

Clarify Refuse-to-File Guidance: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes an FDA draft guidance on refusal to file NDA and BLA submissions to CDER will help manufacturers prepare complete applications that are ready for filing, reducing burdens on industry and the agency both. But it also says that some aspects of the draft guidance should be clarified.

In particular, the comment letter says, the draft guidance focuses on FDA’s policy for refusing to file an NDA and suggests that the reasons specified in the appropriate regulations likewise apply to BLAs. “PhRMA also believes that certain recommendations in the draft guidance relating to ‘review’ issues serving as the basis for a refuse-to-file decision should be clarified,” it says.

The association asks that the draft guidance be revised on applications that are filed over protest to reflect the PDUFA 6 commitment letter, since the draft cites an outdated version of the PDUFA performance goals and should reflect the new commitment letter.

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