Drugs

Making NDA/BLA Development Meetings Better: Parexel

Two Parexel executives write in a Life Science Leader online post that drug developers could make NDA/BLA development meetings with FDA staff more productive by adopting a framework for the discussion that helps them consider the advantages and disadvantages of every option, both with and without FDA advice. The executives say that problems in presubmission meetings can arise because the two sides have different aims.

“Sponsors would like guidance, and preferably certainty, on which development features will make their results acceptable to FDA reviewers,” they write. “Much is discussed in these meetings, but sponsors are primarily looking for what they must do to achieve regulatory approval…. On the other side of the table, FDA regulators generally view presubmission meetings and other interactions with sponsors as opportunities to brainstorm, head off bad ideas, or warn sponsors about potential pitfalls. They shy away from providing absolute clarity … in the hope that sponsors will attend to the broadest possible range of issues that could impact their development plan.”

The authors praise the FDA “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making” for its effort to provide transparency about risk-benefit calculations during the formal review of new drug applications by summarizing the relevant facts, uncertainties, and key areas of judgment and how those factors influence a regulatory decision.

They suggest that sponsors could get more out of presubmission meetings if they used a similarly structured advantages/disadvantages framework to map the decision space around important development questions and FDA responses, and show a hypothetical example of how such a framework might look.

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