Drugs

FDA Probes Data Integrity Concerns at India CRO

FDA is notifying NDA and ANDA holders about data integrity and study conduct concerns with bioequivalence studies conducted at contract research organization (CRO) Raptim, which is based in Navi Mumbai, India. An agency notice says that in vitro studies conducted by Raptim are not acceptable, and if any studies were relied on for any product approval then they must be repeated at study sites that do not have data integrity concerns.

“Applications with in vivo studies conducted by Raptim will be handled on a case-by-case basis during the course of a standard submission review,” FDA says. “Study concerns can be addressed by the applicants with appropriate steps, which may include providing additional information to justify how the data from the studies can still be relied upon, re-analyzing the study samples and re-conducting statistical analysis to demonstrate bioequivalence, or conducting a new study. Sponsors may contact the relevant FDA review division in the Office of Generic Drugs or the Office of New Drugs for further information or clarification.”

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