Drugs

PhRMA Generally Supports Capacity Planning Method

Pharmaceutical Research and Manufacturers of America (PhRMA) says it “applauds FDA for seeking input on the capacity planning adjustment (CPA) methodology and the recommendations being made” in an agency report on assessing the resource needs of PDUFA and BsUFA. Completion of the assessment of CPA methodology meets an agency commitment in PDUFA 6 and BsUFA 2.

PhRMA says it generally supports the new CPA methodology and believes that the recommendations outlined in the report can further enhance the ability of the CPA to align the appropriate resources to the proper program areas and activities.

The association recommends that FDA discuss the report and provide updates on the steps that are being taken to address the recommendations at the annual user fee public meeting. It also says the agency should ensure that the application of the CPA methodology to BsUFA resources addresses the biosimilar review program’s unique needs and that resources are available and proportionate to its workload demands.

PhRMA also provided specific line-by-line comments.

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