Drugs

2 New CDER Bioresearch Monitoring Documents

FDA has issued two documents relating to bioresearch monitoring. A draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring Inspections for CDER Submissions, describes the electronic submission of certain data and information in standardized formats, and supersedes a previous draft guidance. The guidance applies to electronic submissions of data and information from all major (pivotal) studies used to support safety and efficacy claims in NDAs, BLAs regulated by CDER, and supplemental applications containing new clinical study reports. It also applies when these data and information are submitted in certain INDs in advance of a planned NDA, BLA, or supplemental application.

A Bioresearch Monitoring Technical Conformance Guide gives the agency’s current specifications for preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset that are used by CDER for planning of bioresearch monitoring inspections in electronic form for NDAs, BLAs, and NDA or BLA supplemental applications containing clinical data regulated by CDER. It also applies when these data and information are submitted under certain INDs in advance of a planned NDA, BLA, or supplemental application.

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