Biologics

Close Look at Unproven, Unapproved Regenerative Products

FDA commissioner Stephen Hahn and CBER director Peter Marks say it is time that unproven and unapproved regenerative medicine products be identified and recognized as uncontrolled experimental procedures that can cost patients both physically and financially. Writing in the Journal of the American Medical Association, Hahn and Marks say that despite assertions by some individuals to the contrary, the products, whether autologous or allogenic, are not inherently safe and may be associated with serious adverse consequences.

“This is particularly true for those products that are not manufactured consistent with current good manufacturing practice,” they write. “Lapses in good manufacturing practice are likely responsible for numerous serious bacterial infections requiring hospitalization. Such lapses also may be responsible for noninfectious complications due to substances introduced during the manufacturing process…. The increasing number of adverse events being reported following the widespread use of unapproved regenerative medicine therapies at hundreds of clinics across the country make it necessary for FDA to act to prevent harm to individuals receiving them.”

The article discusses the compliance and enforcement actions the agency has taken over the past several years.

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