Drugs

CDER New Drugs Director Jenkins to Retire

After almost 25 years at FDA, and nearly 32 years of federal government service, CDER Office on New Drugs (OND) director John Jenkins will retire effective 1/6/2017. Jenkins joined FDA in 1992 as a medical officer in CDER’s former Division of Oncology and Pulmonary Drug Products. He later served as pulmonary medical group leader and acting division director before being appointed director of the newly created Division of Pulmonary Drug Products in 1995. In 1999, Jenkins was named director of the Office of Drug Evaluation II and served in that position until he was appointed OND director in 2002.

Jenkins played a critical role in designing and overseeing the current managed new drug review process (21^st Century Review), and he implemented multiple process changes mandated by legislation or initiated through user fee agreements. He helped implement the new biosimilars review program, and he created many processes to help ensure consistency with policies and procedures in the new drug review area, including labeling, pediatrics, and safety requirements.

FDA has begun a national search to fill Jenkins’s position. In his absence, CDER director Janet Woodcock will serve as acting director of OND.

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