Drugs

PhRMA Wants ‘More Complete’ Interchangeability Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development Under the BPCI Act, should be revised to provide more complete guidance related to interchangeable products, including on:

consideration for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products;
labeling for interchangeable products;
promotional labeling and advertising considerations for interchangeable products;
quality considerations and further guidance on post-approval manufacturing changes; and
the agency’s approach to reviewing 351(k) applications seeking an interchangeability determination that are (1) in review at the time a first interchangeable product is approved or (2) submitted during the pendency of an interchangeability exclusivity period.

The PhRMA comment letter also asks that the final guidance revise the labeling statement on interchangeability to clarify that the product is interchangeable with the reference product and not with other biosimilar products.

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