Drugs

FDA Guide on Postmarketing Noncompliance Good Cause

FDA has published a draft guidance, Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act, with information for holders of approved applications for human prescription drugs who are required to conduct postmarketing studies or clinical trials under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The document says such applicants must provide certain information to FDA, including a timetable for completing the study or clinical trial and periodic reports on study/trial status.

The guidance describes factors the agency considers when determining whether an applicant has demonstrated good cause for its noncompliance with the timetable for completing postmarketing requirement (PMR) milestones. It also has information on relevant procedures, including how to communicate with FDA about compliance with PMRs, submitting an explanation of the circumstances that led to noncompliance, and how FDA notifies an applicant of a determination of noncompliance.

The guidance applies only to PMRs required under section 505(o)(3) of the FFDCA. It thus does not apply to:

pediatric studies required under section 503B;
trials required as a condition of accelerated approval under section 506(c); and
trials required as a condition of approval based on evidence of effectiveness from studies in animals under regulations.

The guidance also does not apply to nonprescription drugs or to generic drugs approved under section 505(j).

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