Drugs

FDA Finalizes Rule to Require Electronic Drug Registration/Listing

FDA has published a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their registration and listing information. The 2006-proposed rule featured a requirement that FDA, not registrants, develop national drug codes (NDCs) for assignment to listed drugs, and a requirement that the NDC appear in human-readable form on the label of each listed drug — but these were not adopted in the final rule due to opposition in comments received.

FDA says the 2013 Drug Supply Chain Security Act (DSCSA) requires drug manufacturers and repackagers to affix or imprint a product identifier on packages for certain prescription drugs for human use, and the NDC is one component of the standardized numerical identifier. “FDA has determined that because the DSCSA requires the inclusion of NDCs on certain prescription drug labels (as part of a product identifier), it is unnecessary to include the proposed amendments to §201.2 in this final rule,” it 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