Drugs

Stakeholders Comment on Advisory Committee Session

The Biotechnology Innovation Organization (BIO) says it is critical that FDA appoint individuals to advisory committees who have the requisite expertise to consider the topics under discussion and provide expert advice to the agency. BIO’s comments are in a letter responding to an FDA request for information and comments on the agency’s 6/13 public listening session on advisory committee processes.

BIO says it is concerned that agency conflict-of-interest policies often lead to the disqualification of key thought-leading scientists, doctors, and medical experts, meaning that committees may lack the necessary experience or expertise to effectively advise the agency on matters such as the safety, efficacy, and benefit/risk assessment of investigational medicines.

BIO also makes suggestions for ways to ensure that committees can hear diverse perspectives and can better incorporate patient voices.

In its response, Pharmaceutical Research and Manufacturers of America comments on the composition of advisory committees, service on a committee as a Special Government Employee, and public perception and understanding of advisory committees.

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