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F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
FDA Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
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Glenmark Receives FDA Warning for Indore Facility, Ensures No Supply Disruption
An announcement from Glenmark Pharmaceuticals Limited ( ($IN:GLENMARK) ) is now available. Glenmark Pharmaceuticals Limited has received a warning ...
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Just how radical is the FDA's complete response letter move?
The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...
FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
Global Kratom Coalition Applauds FDA Action Against Hydroxie and Expects Broader Crackdown Against Synthetic Opioids Like 7
FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health ...
US FDA publishes 200 complete response letters from archive in transparency drive
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 ...
American Kratom Association Applauds FDA Crackdown on Dangerous Chemically Manipulated 7-OH, Pseudoindoxyl and 'M' Products
Synthetic products posing as kratom mislead and endanger consumers; AKA urges FDA to take decisive action against violative ...
Q’Apel recalls clot removal device in response to FDA warning letter
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.” ...
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FDA stops Olympus devices from entering the US
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...
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Olympus pledges prompt response following FDA import block
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...
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FDA Posts 200 Letters Citing Initial Concerns About Approved Drugs
The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...