Drugs

CDER Launches Controlled Substances Program

CDER has launched its new Controlled Substances Program (CSP) that encompasses the controlled substances staff and controlled substances initiatives. An internal staff memo says the CSP was established to coordinate CDER activities and emerging issues around controlled substances including prescription opioids, benzodiazepines, and stimulants. The memo says the CSP will strengthen the Center’s ability to proactively pursue policies and initiatives to prevent or minimize the risks associated with problematic use of controlled substances and to help enable appropriate access to the products for medical use.

The program is said to give CDER the capability to (1) coordinate and support the Center’s work on controlled substance policies and programs with internal and external stakeholders; (2) facilitate intra- and inter-agency interactions to develop and implement strategies for appropriate access; and (3) provide technical expertise on specific drug applications and drug scheduling.

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