Drugs

Generic Drug Facility Self-Identification Guidance

FDA has issued a guidance, Self-Identification of Generic Drug Facilities, Sites, and Organizations, to inform them about complying with the self-identification requirement in the Generic Drug User Fee Amendments of 2012 (GDUFA). Under that law, the document says, human generic drug facilities, sites, and organizations are required to annually submit identification information to FDA electronically. Topics covered in the guidance include:

which types of generic facilities, sites, and organizations are required to self-identify;
what information is requested;
what technical standards are to be used for electronically submitting the requested information; and
the penalty for failing to self-identify.

FDA says that self-identification is necessary for two purposes. First, it is needed to determine the universe of facilities required to pay user fees. And second, it is a central component of an effort to promote global supply chain transparency. “The information provided through self-identification enables quick, accurate and reliable surveillance of generic drugs and facilitates inspections and compliance,” the agency says.

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