Drugs

2026 Warning Letter Trends Analyzed by Attorney

Attorney Megan Robertson (Epstein Becker Green) says the biggest trend in FDA Warning Letters so far this year has been the agency’s crackdown against online telehealth platforms that offer compounded GLP-1 drugs. Appearing in a brief video, Robertson says FDA’s push is for the companies to clean up their Web sites and marketing materials to ensure that the delineation of services they provide as healthcare professionals is distinct from the drugs being compounded and sold by pharmacies.

“CDER has certainly been the most active Center to date,” she says, “not only with its GLP-1 letters to telehealth companies, but also with several letters to manufacturers, both domestic and foreign, citing current good manufacturing practice concerns in a variety of contexts.”

Robertson lists these additional key takeaways from her Warning Letter analysis:

· FDA is monitoring Web sites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status;

· CDER is actively enforcing CGMP compliance. Recalls alone do not satisfy FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.

· food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.

· form FDA-483 responses are receiving heightened scrutiny and medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.

· because the Warning Letters were issued under the former FDA commissioner, in-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

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

Read more

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