Biologics

Regenerelle Marketing Unapproved HCT/P Products: FDA

The CBER Office of Compliance and Biologics Quality says its review of a Web site and YouTube channel maintained by AT Venture Center for Global Techtrepreneurship, doing business as Regenerelle in Fairport, NY, determined that the firm is marketing a human mesenchymal stem cell product intended to treat various diseases and conditions. A 5/22 Notice of Violation says the firm’s products are human cell, tissue, or cellular or tissue-based products (HCT/Ps) that are regulated as both drugs and biologics.

The letter says the products require an approved BLA or IND and refers Regenerelle to the agency’s comprehensive regenerative medicine policy framework for HCT/Ps “which is intended to spur innovation and efficient access to safe and effective regenerative medicine products.”

FDA also notes that Regenerelle markets exosomes and says that as a general matter exosome products intended to treat diseases or conditions in humans are also regulated as drugs and biologics and subject to premarket approval.

The letter asks for a written response from the company.

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