Drugs

Regenerative Meds Approval Bill Introduced

Sens. Mark Kirk (R-IL), Joe Manchin (D-WV), and Susan Collins (R-ME) have introduced legislation that includes a conditional approval pathway for new regenerative medicine treatments that have the potential to restore or establish normal function in damaged human cells, tissues, and organs. Companion legislation was introduced in the House by Rep. Mike Coffman (R-CO).

The REGROW Act (S. 2689) reportedly addresses a lack of regulatory standards identified by FDA as an impediment to treatment development. It would require the agency to collaborate with stakeholders to develop standards that will lead to manufacturing processes and controls for safe regenerative products. It also would protect existing drug approval pathways under Sections 351 and 361 of the Public Health Services Act and create a new approval for regenerative medicine products.

The sponsors say in a statement that countries like Japan and England are outpacing the U.S. in regenerative medicine therapy development due to new regulatory policies that the U.S. has yet to adopt. They say their legislation builds on a 12/2015 Bipartisan Policy Center report that contained recommendations for advancing regenerative cellular therapies by establishing a novel, conditional approval pathway that will ensure that products are safe and effective before they can be marketed and post-market surveillance measures to ensure continued safety during the conditional use period.

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