The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

An announcement from Glenmark Pharmaceuticals Limited ( ($IN:GLENMARK) ) is now available. Glenmark Pharmaceuticals Limited has received a warning ...

The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...

By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health ...

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination, two sources said.

Rather than pursuing a new regulatory pathway, Q'Apel said it is discontinuing the recalled system “as part of its strategic shift toward newer technologies.” ...

Synthetic products posing as kratom mislead and endanger consumers; AKA urges FDA to take decisive action against violative ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...