Drugs

BioMarin Wants Better CDER/Sponsor Communications

Commenting on an FDA 11/7/19 public meeting on opportunities and priorities for the CDER Office of New Drugs (OND) in promoting effective drug development programs, BioMarin says OND should support the practice of review teams and division directors who facilitate open, early, and frequent communication between review staff and drug sponsors. “Particularly in areas of unmet need,” the comment letter says, “a collaborative approach to interactions between sponsors and FDA during drug development is essential to overcome the inevitable challenges that arise during research and development.”

The American Association for Cancer Research says that “continuing stakeholder engagement will be integral to the OND achieving its goals of identifying areas in need of and strategies for providing regulatory clarity for the purpose of facilitating the development and review of safe and effective medical products.” It suggests that OND use case study-focused workshops to discern stakeholders’ views and identify best practices for the use of novel trial designs and to familiarize both stakeholders and FDA with innovations in drug development as they arise.

Denali Therapeutics asks that OND consider harmonizing the level of nonclinical evidence required by the various divisions across the development of new therapies for serious and life-threatening diseases.

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