The Food and Drug Administration has issued the first known letter acknowledging that a pharma company it had flagged during its initial September flurry of Untitled Letters over improper marketing of ...
The U.S. Food and Drug Administration (FDA) has officially dropped its warning letter and enforcement complaint against Whoop ...
Morning Overview on MSN
The FDA sent 25 warning letters to telehealth sellers over misleading weight-loss drug claims
The FDA fired off warning letters to 25 telehealth companies this month for making false or misleading claims about ...
Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor ---- FDA inspection of third-party ...
The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.” The missive marks the first ...
The U.S. Food and Drug Administration (FDA) sent over 50 warning letters to GLP-1 drug compounders and manufacturers in September 2025. The agency warned the companies that their statements that ...
The Food and Drug Administration (FDA) has sent out 12 more Untitled Letters to pharma companies amid its ongoing crackdown on direct-to-consumer (DTC) advertising. The agency quietly posted the new ...
FDA tied AI-assisted drafting directly to established Quality Unit accountability under 21 CFR 211.22(c) for approving/rejecting specifications and procedures affecting identity, strength, quality, ...
A recently issued Food and Drug Administration (FDA) Warning Letter citing a drug manufacturer for improper use of artificial intelligence (AI) suggests FDA’s scrutiny of AI is expanding. Although not ...
Analysis: Monitoring-related enforcement actions grew nearly 200% between 2021 and 2025, according to a review of 3,286 FDA warning letters ...
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