Drugs

CDER BIMO Inspections Down in 2015

There were 1,017 CDER inspections overseen by the Office of Scientific Investigations and Office of Study Integrity and Surveillance in 2015, down from the 1,041 inspections in 2014. OF the total, 430 were clinical investigator inspections, 319 dealt with bioequivalence, 92 involved postmarketing adverse drug experience, and 84 were for Risk Evaluation and Mitigation Strategy. Bioresearch monitoring metrics issued by the two offices show that there were 562 domestic inspections in 2015 and 357 foreign inspections. The number of domestic inspections was much higher in the previous year at 623, while the number of foreign inspections was much lower at 313.

Some 47% of BIMO (bioresearch monitoring) inspections in FY 2015 were of clinical investigators, while 35% was on bioequivalence and 9% involved institutional review board/radioactive drug research committee.

Of the clinical investigator inspections, 430 (58%) were through CDER, 211 through (28%) CDRH, and 101 (14%) through CBER. The final classification for those inspections was no action indicated for 59%, voluntary action indicated for 37%, and official action indicated 4%.

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