Drugs

Drug Communication Best Practices Guidance Out

FDA has published a draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, outlining best practices and procedures for timely, transparent, and effective communications between IND sponsors and the agency at critical junctures in drug development. The document describes:
FDA’s philosophy about timely interactive communication with IND sponsors as a core activity; the scope of appropriate interactions between the review team and the sponsor; the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program; general expectations for the time of agency response to IND sponsor inquiries; best practices and communication methods to facilitate interactions between the FDA review time and the IND sponsor during drug development; and expectations for appropriate methods, including the frequency, of such communications.

The guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing an IND development program. CDER and CBER agreed to jointly develop and publish the guidance under one of the PDUFA 5 goals.

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