Drugs

Expedited Pathways Getting Good Use: Woodcock

CDER director Janet Woodcock says the Center’s regulatory pathways that expedite the development and approval of new drugs received significant use in 2017. Writing in a report on new drug therapy approvals in 2017, Woodcock reviews usage of the fast track, breakthrough therapy, priority review, and accelerated approval expedited pathways. Overall, she says, 28 of the 46 novel drug approvals in 2017 were designated in one or more of the expedited categories.

Some 18 drugs received fast track designation, Woodcock said, which speeds new drug development and review by, for instance, increasing the level of communication between FDA and developers, and by enabling CDER to review portions of a drug application ahead of the submission of the complete application.

In 2017, CDER designated 17 of the novel drugs as breakthrough therapies. Woodcock said that designation includes all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.

Priority review allows a drug to be reviewed within six months, instead of the standard 10 months. CDER gave that review to 28 of the 46 novel drugs approved in 2017.

Finally, the accelerated approval program gives the agency more flexibility in what endpoints can be used to approve a drug that offers a benefit over current treatments for a serious or life-threatening illness. In 2017, Woodcock says, CBER approved six drugs under this pathway.

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