Drugs

Synapse Labs Studies ‘Unacceptable’: FDA

FDA is notifying NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synapse Labs Pvt. Ltd. in Pune, India, are not acceptable due to data integrity concerns. An agency online notice says that studies conducted by Synapse must be repeated.

“During analyses of study data generated at Synapse in several applications, FDA identified significant unexplained anomalies in the data that indicates the data were falsified,” the notice says…. “FDA is requiring sponsors of approved, tentatively approved, or pending ANDAs and NDAs to repeat the bioavailability/bioequivalence studies, when these studies are essential for approval, using an entity other than Synapse or any other organization with known unresolved data integrity concerns.”

The notice says the agency is changing the therapeutic equivalence rating to BX for any currently approved and marketed prescription generic applications that relied on data from Synapse until adequate repeat studies are submitted and determined to be adequate to demonstrate bioequivalence. The BX rating indicates data reviewed by the agency are insufficient to determine therapeutic equivalence of the generic product to its brand-name product. Drugs with a BX rating are still approved and can be prescribed, FDA says, but are not recommended as automatically substitutable at the pharmacy for the branded drug.

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