Drugs

NDA Approvals Down in U.S., Level in EU: Consultants

NDA Group says its fourth annual comparison of drug approvals in the U.S. and Europe shows a drop in U.S. approvals, but not in the European Union. For 2016, the report says, there were 74 new drug approvals granted in the U.S. and EU. Of those new products, 19 were approved only in the U.S., 19 only in the EU, and 36 were approved in both regions. However, the firm says, 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the U.S., while only six products registered in the U.S. in 2016 were previously approved in the EU.

The firm’s research consultant who prepared the report said, “The findings show that FDA has had a significant drop in drug approvals but continues to grant more expedited and non-standard review approvals than the EMA (European Medicines Agency). The drop is not as pronounced in the EU but is likely to be more prominent in 2017. Expedited drug development and non-standard review approval pathways are the new norm in the U.S., but in the EU special approval procedures are not as common. The U.S. situation could be explained by the increased use of the shorter non-standard approval pathways since there has been a significant increase in complete response letters (CRLs). During 2016 FDA issued 14 CRLs, compared to just two in 2015.”

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