Drugs

ANDA Complex Product Meeting Guidance

FDA has published a guidance, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA, describing an enhanced pathway for discussions between the agency and applicants for ANDAs for a complex product, as defined in the guidance. The document specifically provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA, it says.

The guidance reflects a unified approach to all formal meetings between the agency and ANDA applicants or prospective applicants for complex products, FDA says.

First published as a draft 10/2017, the guidance:

defines complex generic drug products for the purposes of the meetings;
defines meeting types;
provides related GDUFA 2 performance goals;
offers recommendations for meeting requests; and
provides general information on FDA assessment of meeting requests, rescheduling or canceling meetings, meeting package content and submission, pre-meeting communications, the conduct of meetings, and meeting minutes.

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