Drugs

Comments on Pediatric Clinical Pharmacology Draft

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biological products, will “help improve the collection of clinical pharmacology information, such as pharmacokinetics and pharmacodynamics data, to better inform dose selection and individualization in the pediatric patient population.” In a comment letter, PhRMA says additional clarifications to some topics would be helpful.

It asks for further clarification and examples for clinical pharmacology considerations for biologics, physiologically-based pharmacokinetics models, and additional clinical pharmacology considerations. PhRMA also provides specific line-by-line comments.

The Biotechnology Innovation Organization (BIO) says it appreciates FDA’s revisions to a 2014 version of the draft guidance that were informed by feedback from its industry colleagues. BIO provided general comments on the draft scope, recommended additional content and clarification, and alignment with U.S. and global guidelines. It also included 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