Drugs

Rule on Master Files and Biologics

FDA is issuing a final rule to amend its regulations about the use of master files for biological products. The agency describes a master file as a submission that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Information contained in a master file can be used to support a submission to FDA by an applicant or sponsor.

“The rule codifies FDA’s existing practice that applications for a biological product under the Public Health Service Act (PHS Act) may rely on a master file for information other than [drug substance, drug substance intermediate, or drug product] DS/DSI/DP information,” an agency notice says. “Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), certain drug applications for biological products approved under section 505 of the FD&C Act were deemed to be biological licenses under section 351 of the PHS Act on 3/23/2020. This rule also codifies that such deemed biological license applications (BLAs) that originally referenced DMFs for DS/DSI/DP information in an approved new drug application can continue to do so after 3/23/2020.”

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