Drugs

Data Integrity Issues at Synapse Labs: Petition

A Flag Pharma citizen petition is asking FDA to revisit the therapeutic equivalence ratings for generic drugs that relied on bioequivalence studies performed by Maharashtra, India-based Synapse Labs between 2009 and 2023 after Spanish regulatory authorities inspected the facility and documented data integrity and pharmacokinetic anomalies. “Such findings raise questions about the accuracy and sufficiency of the bioequivalence studies performed at the facility — both in applications pending and applications already approved,” the petition says. It also requests that FDA require sponsors to repeat bioequivalence or relevant studies performed by Synapse Labs to reassess therapeutic equivalence.

The petition notes that contract lab Synapse was inspected by FDA in March 2023, resulting in a “no action indicated” rating, and it questions how Spanish regulators documented “diametrically opposed" findings. Specifically, the Spanish inspection raised “serious doubts on the validity and reliability of the data of BE [bioequivalence] studies (clinical and bioanalytical part) conducted at the CRO,” the petition contends.

Additionally, the petition asks FDA to change affected products’ therapeutic equivalence codes from an “A” rating to a “BX” rating, reflecting that existing data are “insufficient” to determine therapeutic equivalence until additional testing can be performed.

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