Drugs

PhRMA Proposes Changes to Opioid Benefit/Risk Framework

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to develop a benefit/risk framework for approving prescription opioid medicines that accounts for public health concerns. In its comment on an agency draft guidance, PhRMA proposes:

FDA revise the draft to state more clearly that under the Federal Food, Drug, and Cosmetic Act (FFDCA), for purposes of approval, an NDA need not contain evidence comparing an opioid’s safety or effectiveness to another drug;
The draft guidance should clearly distinguish between information that FDA must evaluate under the FFDCA for approval of an NDA and optional information that could provide additional context for considerations within a benefit/risk framework but is not required for approval under the FFDCA.
FDA continue its commitment to encourage development of abuse-deterrent formulations and using a flexible, adaptive approach to working with industry on the evaluation and labeling of potential abuse-deterrent formulations.

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