Drugs

GDUFA 3 Looks at Approving ANDAs Earlier

FDA and the generic drug industry are each offering proposals to advance earlier ANDA approvals, according to minutes of a 10/1 Generic Drug User Fee Amendments negotiation meeting. Industry representatives focused on proposals around a pre-submission of facility correspondence program, transparency and communication enhancements, and greater use of the information requests and other communications to move an application to approval in a single cycle, the document says. FDA reportedly wants to focus on “applications that are ready for assessment, timely responses to complete response letters raising minor issues, opportunities for more efficient review of amendments submitted in response to facility deficiencies, the pre-submission of facility correspondence program, applications with data reliability issues, and drug master files.”

At a 10/15 negotiation meeting, FDA and industry discussed further the pre-submission facility correspondence program to clarify and understand how the information submitted enables the agency to make a determination of whether or not an inspection is needed, and which information is most critical. They also discussed industry’s challenges with meeting these needs. Both parties agreed to discuss the proposals at their next meeting.

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