Drugs

Pregnancy, Lactation, Reproduction Draft Guidance

FDA has published a draft guidance, Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in complying with the content and format requirements for human drug and biological products labeling subsections on pregnancy, lactation, and females and males of reproductive potential. The document gives recommendations on complying with the 2014 pregnancy and lactation labeling final rule (PLLR) for NDAs and BLAs or efficacy supplements. It also has recommendations to applicants that have previously submitted NDAs, BLAs, and efficacy supplements to approved NDAs or BLAs during specified periods.

The guidance revises a 12/2014 draft guidance with:

information on formatting, omitting information, and pregnancy registries pertinent to PLLR labeling;
clarifying information related to the risk summary heading, risk statements, and human and animal data, pertinent to PLLR labeling;
information on labeling for the subsection on females and males of reproductive potential, with information on pregnancy testing, contraception, and infertility; and
procedural information on PLLR implementation and submission of draft labeling that complies with PLLR to the agency for review.

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