Biologics

Regenerative Therapies Expedited Programs

FDA has published a draft guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, with the agency’s recommendations on the expedited development and review of such therapies. The document describes the expedited programs available to sponsors of regenerative medicine therapies for serious conditions, including those products designated as “regenerative medicine advanced therapy” (RMAT).

The guidance says it provides information about the provisions in the Cures Act regarding the use of the accelerated approval pathway for regenerative medicine therapies that have been granted an RMAT designation. It also describes considerations in the clinical development of regenerative medicine therapies and opportunities for sponsors of such products to interact with CBER review staff.

When finalized, the draft will supersede the 2/2019 final guidance on the same topic. Issuing the draft fulfills a commitment in the PDUFA 7 reauthorization letter, FDA says.

The document contains an Introduction, Background, Expedited Programs for Regenerative Medicine Therapies, Considerations in Clinical Trial Design, Interactions Between Sponsors and CBER Review Staff, and References.

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

Read more

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