Drugs

Target Product Profile Benefits Education Needed: CDER

Three CDER staffers say that drugs and biologics approved by FDA that mention target product profiles (TPPs) are associated with more efficient regulatory review times, perhaps because of increased planning or because the TPP promotes well-organized regulatory dialog. Writing in CellPress, the three say that TPPs are used as a regulatory tool for dialog on clinical development or manufacturing plans.

The difference in regulatory review times seems to suggest a beneficial role of TPPs as a means of focusing discussion on labeling claims or potential manufacturing issues, the article says.

They point out that TPPs are used infrequently and late in the development process. “We suggest that increased education about the benefits of this regulatory communication tool may promote more frequent and appropriate use of TPPs with the aim of shortening the entire development cycle and using development and regulatory resources more efficiently and effectively,” the authors say.

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