FDA Policy/General

AMA Urges FDA to Uphold ‘Rigorous Standards’ for Botanicals

The American Medical Association (AMA) is urging FDA to “uphold rigorous, evidence-based standards for evaluating botanical drug products,” warning that products marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established.

In comments to FDA, the AMA emphasized that botanical products — including kratom, cannabis and other plant-derived substances — should be subject to the same scrutiny as other drugs. “Growing consumer use, anecdotal claims and marketing by social media influencers should not circumvent the FDA approval process or replace the requirement for high-quality clinical trials and postmarket safety monitoring,” the group says.

The AMA commended the agency’s safety assessments that formed the basis behind a Drug Enforcement Administration emergency scheduling of three kratom-related compounds in August.

The letter also urged FDA to ensure that botanical products and their derivatives demonstrate safety and efficacy through clinical trials before being marketed or prescribed to treat medical conditions. It stressed that agency decisions should not be swayed by political considerations, conflicts of interest or commercial pressure that could put patients and the public at risk.

Review Extended on Agios sNDA for Sickle Cell Drug

FDA has extended by three months its review of an Agios Pharmaceuticals supplemental NDA for mitapivat, an oral pyruvate kinase (PK) activator, for treating sickle cell disease. The user fee review action target date is now 2/1/2027. The company says FDA recently requested additional information to evaluate whether

Cassidy Proposes New FDA Review Authorities for AI Medical Devices

FDA Removes More Estrogen Patch Boxed Warnings

FDA has approved revised labeling for three additional estradiol transdermal patch products, removing boxed-warning statements about cardiovascular disease, breast cancer and probable dementia, HHS announced 10/30, prompting renewed criticism over the agency's decision to proceed without a formal advisory committee meeting or publicly presenting detailed scientific

CBER Warns Against Unsupported Survival Claims in Biologic Promotions

CBER’s Advertising and Promotional Labeling Branch (APLB) is warning biologic marketers against using progression-free survival and overall survival data from single-arm studies to support promotional claims that cannot be substantiated by the underlying clinical evidence. Speaking at a 10/28 Food and Drug Law Institute advertising and

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Review Extended on Agios sNDA for Sickle Cell Drug

Cassidy Proposes New FDA Review Authorities for AI Medical Devices

FDA Removes More Estrogen Patch Boxed Warnings

CBER Warns Against Unsupported Survival Claims in Biologic Promotions