Drugs

MEI Electronic Submission Draft Guidance

FDA has published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act about valid electronic submissions of manufacturing establishment information (MEI). The document says that 24 months after the draft has been finalized, MEI in NDAs, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in the guidance. The draft also applies to drug master files that are submitted for incorporation by reference into an NDA, ANDA, or BLA, it says.

In the guidance, the agency calls attention to the deliberate omission of boilerplate language in most guidances that indicates they should be considered only recommendations unless specific regulatory or statutory requirements are cited. “FDA is not including this standard language in this guidance because it is not an accurate description of this guidance,” it says. “Insofar as this guidance specifies the format for electronic submissions pursuant to section 745A(a) of the Federal Food, Drug, and Cosmetic Act, it will have binding effect.”

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

Read more

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