Drugs

Green List to Block Illegal GLP-1 Imports: FDA

FDA has launched a new “green list” import alert aimed at preventing unapproved and potentially unsafe GLP-1 drug ingredients from entering the U.S. The move comes as demand surges for drugs such as semaglutide and tirzepatide, which are FDA-approved for weight management and Type 2 diabetes. The agency notes that some patients have turned to compounded versions of the drugs, which are not FDA-approved and have raised safety concerns.

Under the new policy, only GLP-1 active pharmaceutical ingredients (APIs) sourced from facilities that the FDA has inspected or reviewed and found to comply with U.S. standards will be placed on the “green list.” APIs from all other sources may be detained without physical examination at the border, an agency notice says.

FDA says it previously identified “serious concerns with compounded versions of semaglutide and tirzepatide, including dosing errors, use of unapproved salt forms and adverse events — some requiring hospitalization.” It adds that it will continue to monitor the market, collaborate with state regulators, and pursue enforcement actions against violators in order to protect the integrity of the U.S. drug supply chain.

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