Drugs

Combination Product Review Practices Work Well: Report

An assessment of combination product review practices under PDUFA 6 indicates that the practices are generally considered by the product sponsors and agency reviewers to be effective and efficient despite some challenges. The just-released 8/7 assessment by Lexington, MA-based Eastern Research Group, Inc. says:

request for determination (RFD) and pre-RFD review practices are fundamentally sound and could be enhanced by some straightforward refinements;
the Inter Center Consult Request process is fundamentally sound and could be made more efficient by addressing technology challenges and implementing some good practices; and
combination product IND, NDA, and BLA submission and review practices are largely similar to those of noncombination products and are fundamentally sound and could be enhanced by implementing minor refinements to certain guidances and practices.

The assessment by an independent third-party was one of the FDA commitments under the PDUFA 6 reauthorization.

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