Drugs

‘Exceedingly Burdensome’: PhRMA to FDA on Reporting Guide

An FDA draft guidance on reporting the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act would be “exceedingly burdensome,” Pharmaceutical Research and Manufacturers of America tells the agency in a comment letter. It notes that drug company data collection practices vary from product to product and company to company, and because of this variability in manufacturers’ data collection practices, “it is anticipated that implementing the 510(j)(3) reporting requirements will be exceedingly burdensome, particularly for complex supply chains. Therefore, to ensure that FDA and manufacturer resources are focused on those issues most critical to public health, PhRMA encourages FDA to take a phased approach to the implementation of these reporting requirements, to describe how the agency intends to use the reported data to mitigate against drug shortages, and to focus the agency’s limited resources on the optimization of existing quality oversight tools and initiatives that will have the greatest impact in enabling FDA and manufacturers to prevent and mitigate drug shortages.”

The letter also makes specific recommendations for changes.

Additional specific comments were provided by the Biotechnology Innovation Organization and Pfizer.

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