Drugs

More Complete Response Letters, Fewer Drug Approvals: Jenkins

CDER is issuing more complete response letters this year, and it is significantly reducing the number of new molecular entity (NME) approvals, retiring Office of New Drugs director John Jenkins says in his annual review of the Center’s approval performance. Factoring in fewer NME submissions and five applications that were targeted for approval this year but instead received early approvals at the end of 2015, the end result is just 19 applications approved in 2016 compared with 44 such approvals last year. Overall, CDER’s approval action rate has fallen from 96% in 2015 to 61% projected with just two weeks left in the calendar year.

Complete response letters have skyrocketed from two issued last year to 12 this year, with several due to manufacturing-related issues holding up approval, according to Jenkins’ stats. To date, NME submissions are tracking at the Center’s 10 year average. Approval times this year show positive improvement — landing at 7.8 months (overall NME NDA/BLAs median total time to approval), which is the lowest since the user fee program began in 1993.

Jenkins notes that CDER continues to ensure the efficiency of first cycle review, and all but one (95%) of the novel drugs approved to date this year met their user fee goal dates. Additionally, almost all (95%) of the novel drugs approved this year, were approved in the first review cycle.

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