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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.
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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 ...
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 ...
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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 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 ...
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 ...
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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 ...
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 stalls in posting food safety warning letters amid staff cuts
The Food and Drug Administration laid out these inspection findings in warning letters, accusing the companies of committing “significant violations” of federal laws, according to an FDA staff ...
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 ...
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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 ...
Cookie Recall Update as FDA Warning Issued to Customers in 15 States
The recall will remain active until the FDA and Carley's Inc. have resolved the labeling issue and ensured that all misbranded products are removed from the market. Consumers who have purchased ...