Drugs

EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland

An ongoing European Medicines Agency (EMA) and FDA joint initiative on information sharing involving generic drug bioequivalence study inspections has just grown by one more EU Member state — Ireland. The countries now participating in the FDA/EMA information sharing pact are: Austria, France, Germany, Ireland, Italy, The Netherlands, Spain, and the U.S., according to an EMA release.

The joint initiative was established in 2013 and it included a mechanism for conducting joint inspections of facilities where the bioequivalence studies were conducted. The bioequivalence studies pact grew out of a 2009 EMA-FDA Good Clinical Practice Initiative that was designed to ensure clinical trials submitted in marketing applications in the U.S. and Europe are conducted ethically and that the data generated are reliable.

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