Drugs

Comments on FDA Bridging Draft Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that additional clarify and increased consistency from FDA on the bridging of information approaches for drug-device and biologic-device single entity and co-packaged combination products promote efficiency in the development process that can lead to timely access to new and improved products for patients. The association’s comment on an FDA draft bridging guidance also says sponsors would benefit from an FDA-hosted Webinar focused on the draft guidance before it is finalized. “Such a Webinar or public meeting could clarify the specifics of each case study in the draft guidance and contribute to a greater shared understanding of FDA’s recommendations for bridging information in combination product development efforts,” the letter says. PhRMA also provides specific text comments.

The Association for Accessible Medicines recommends that additional clarify be added throughout the guidance further detailing the information linking the content and applicability to 505(j) and 351(k) applications. It also provides technical line-by-line comments.

A Biocon comment letter contains specific technical 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