Drugs

Alliance for Regenerative Medicine AMT Concerns

The Alliance for Regenerative Medicine (ARM) says it is concerned that an FDA draft guidance, Advanced Manufacturing Technologies Designation Program, “fails to provide a clear framework for the adoption of advanced manufacturing technologies (AMT) across the cell and gene therapy industry.” In its comment letter, ARM questions the agency’s decision to have an approach for BLA sponsors that differs from that used by NDA/ANDA sponsors.

“ARM agrees with the agency that a BLA application holder is, and should be, responsible for ensuring the quality of the product and, therefore, understands the regulatory intent behind FDA’s requirements that certain chemistry, manufacturing, and controls information need to be contained within the BLA and not referenced through a drug master file or otherwise,” the letter says. “However, these requirements have hindered technology development and adoption in cell and gene therapies and we are disappointed that these requirements were codified by FDA after the release of this guidance without regard for the statute governing the AMT designation program.”

The letter also says there are key aspects of the data submission process that ARM believes need correction or additional clarification and details.

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