Drugs

Bioavailability Studies Guidance Comments

Merck says it would be helpful if FDA would include in a draft guidance on bioavailability studies submitted in NDAs or INDs the reason or trigger for revising the 3/2014 draft guidance and a summary of key changes from the 2014 document.

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports agency publication of the draft guidance and appreciates the transparency in FDA’s thinking about the requirements for conducting bioavailability studies and the information FDA expects sponsors to submit to support an application. “PhRMA believes the draft guidance will help further ensure the quality of bioavailability studies,” the letter says, “improve the consistency of study analysis provided in INDs and NDAs, and aid evaluation of drug safety and effectiveness.”

Both stakeholders also submitted specific, 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’

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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

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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