Drugs

FDA Wants CNS Stimulant Abuse Deterrence Comments

FDA has established a public docket soliciting comments from patients, patient advocates, healthcare professionals, academics, researchers, the pharmaceutical industry and other government entities on considerations relating to the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system stimulants. Comments are also sought on whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse, according to a Federal Register notice.

An agency statement says that although FDA has approved multiple ADF opioid analgesic products with language in the drug labeling stating that the products are expected to deter abuse via specific routes of administration, it has not approved similar labeling for any prescription stimulants.

The notice gives an overview of available postmarket data on the use, misuse, and abuse of prescription stimulants and associated harms, with data on opioid analgesics provided for context. It also provides background information on the development and evaluation of ADF products and questions for which the agency is seeking input.

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