Drugs

Gottlieb Praises Drug Approvals, Other 2017 Successes

FDA commissioner Scott Gottlieb says 2017 was “an inspiring year of advances in both medicine and public health for FDA, from groundbreaking medical products brought to market this year to a record number of generic drug approvals that will promote competition, and to the agency’s ongoing efforts to advance policies that promote safe and effective product innovation….” In a year-end retrospective FDA Voice online post, Gottlieb says the agency approved 56 novel drugs and biologics in 2017.

Of the 56 approvals, he writes, 46 were new molecular entities approved by CDER, and 10 were biologic therapeutics approved by CBER. Of the 46 CDER drugs, 28 were approved using one or more expedited review programs.

“We also had a record number of drugs with orphan indications approved,” Gottlieb says. “At the same time, we eliminated the entire backlog of pending orphan drug designation requests. We also broke records with the highest number of generic drugs approved in a single month multiple times in 2017, and we recorded the highest annual total of generic drug approvals (1,027) in the agency’s history.” He projects a new record total of generic drug approvals in 2018.

Other topics in this year-end review include medical devices, modernizing regulatory programs, promoting drug competition, new steps to combat addiction, protecting and empowering consumers, improving stewardship of vital drugs, and a look ahead to 2018.

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