Drugs

FDA Approving Drugs Faster Than EMA: Analysis

Three researchers who compared drug review and approval times between 2011 and 2015 for FDA and the European Medicines Agency (EMA) say that FDA is consistently faster. Writing in a letter to The New England Journal of Medicine, the researchers conclude that their analysis “provides reassurance that FDA continues to complete regulatory reviews more quickly than the EMA and has the potential to inform discussions regarding the reauthorization of PDUFA.”

The letter notes the reforms intended to further streamline FDA review included in the recently-approved 21^st Century Cures Act and says that the speed of the regulatory review process is directed by PDUFA, which will be considered by Congress for authorization before it expires in October.

In their analysis, the authors found that FDA approved 170 new therapeutic agents between 2011 and 2015, while the EMA approved 144. The therapeutic areas of the approvals were similar for the two agencies, although more orphan drugs were approved by FDA than the EMA. The median total review time was 306 days (range of 239-371 days) for FDA and 383 days (range of 327 to 446 days) for the EMA.

“The total review times were shorter at FDA than at the EMA for therapeutic agents that are used for the treatment of cancer and hematologic disease, but not for other therapeutic areas, and for therapeutic agents that were designated as orphan drugs,” the authors say.

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