Drugs

Woodcock Sees 6 Forces Driving Drug Development

CDER director Janet Woodcock says that multiple forces are driving drug development and the generic drug industry and their regulators need to be ahead of those trends. In a presentation to the 2017 Generic Pharmaceutical Association annual conference, Woodcock identified the forces as international regulatory convergence, advanced manufacturing, rise of biosimilars, new science and technology, the digital revolution, and drug costs.

After discussing each of the forces, she looked at the Generic Drug User Fee Agreement 2 and the ways in which it prepares for the future, including (1) focused research to enable approval or more streamlined development of non-oral dosage forms; (2) availability of advice up front on complex drug development; and (3) interaction and guidance.

She also said that CDER is planning for the future through product lifecycle management; consistent, documented, automated procedures that are scalable; and continuing to improve electronic submissions to streamline the process and reduce cycling so that the Center and industry can concentrate on getting work out and preparing for the future.

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