Drugs

Enforcement Discretion Extended on Regenerative Therapies

FDA is extending by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) due to the Covid-19 public health emergency. The extension will provide manufacturers and potential sponsors an additional six months to determine if they need to submit an IND or a marketing application.

FDA’s current policy was articulated in its 11/2017 regenerative medicine policy framework, which was developed to help facilitate and support the innovation of regenerative medicine therapies. The agency also outlined its intent to exercise enforcement discretion, until 11/2020, for certain regenerative medicine products. Now, FDA is revising a guidance to reflect that it generally intends to exercise enforcement discretion with respect to IND and premarket approval requirements for certain HCT/Ps through 5/2021.

“To be clear, our policy of enforcement discretion only pertains to certain human cell, tissue and cellular and tissue-based products that do not raise potential significant safety concerns or reported safety concerns,” CBER director Peter Marks said in a notice. (XXINSERT LINKXX). “This policy was never intended to provide a cover for bad actors, and we intend to continue to take action against manufacturers and health care providers who are offering unapproved regenerative medicine products that have the potential to put patients at significant risk.”

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