FDA Policy/General

Inter-Center Communication Lacking: BIO

The Biotechnology Innovation Organization (BIO) says there is a lack of cohesive process for programs involving multiple FDA Centers, specifically CDER and CDRH. Commenting on an agency draft guidance on best practices for communication between IND sponsors and FDA during drug development, BIO says FDA should specifically address combination products and diagnostics to ensure that inter-Center communication and coordination are adequately addressed. “These best practices should ensure that the appropriate Center/Division responds to questions directly related to their area of responsibility and expertise, and that there is formal coordination between Centers when developing agency feedback or a position on topics overlapping between Centers/Division,” the trade group says.

The letter says that BIO strongly supports the PDUFA 5 program to enhance FDA-sponsor communication and applauds agency efforts to give IND sponsors and FDA review staff best practices and procedures for timely, transparent, and effective communications during drug development through the draft guidance.

In past comments, BIO says, it identified four main areas where communications improvement could enable a more effective development and review process — improving scientific dialog, improving effectiveness of formal meetings with FDA, improving communications between FDA and sponsors on emerging and evolving science, and communication improvements to the agency Web site. “We are pleased that FDA discusses and provides recommendations on these topics in this draft guidance,” it says.

The letter includes detailed line-by-line comments.

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