Drugs

ANDA Clinical Study Dataset Guidance

FDA has issued a guidance, Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications, with recommended technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data from ANDAs should be submitted using FDA-supported data standards in the FDA Data Standards Catalog. The document provides additional information related to the agency’s eStudy Data guidance that implements electronic submission requirements of the Federal Food, Drug, and Cosmetic Act.

The guidance is intended to complement interactions between applicants and FDA review divisions, the agency says, and not intended to replace the need for applicants to communicate directly with review divisions about approaches or issues relating to data standards. Detailed specifications are provided for these clinical studies:

the adhesion study for transdermal delivery systems and topical patches;
the irritation/sensitization study for transdermal delivery systems and topical patches; and
the comparative clinical endpoint bioequivalence study using several listed primary endpoints.

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