JD Supra4d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
FDA Changes Raise Concerns About Food Recalls
The number of hospitalizations and deaths from foodborne illness doubled last year compared to 2023 in the U.S.
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Unapproved Drugs in the US and FDA Enforcement
Despite evolving federal regulations, unapproved drugs that have been reviewed by the United States (US) Food and Drug Administration (FDA) are still available and being marketed, thus giving the ...
Fox News3d
FDA recalls more than 2 million cases of doughnuts
The Food and Drug Administration has classified a recall of 60 different doughnut products to its second-highest level, the agency announced earlier this week in an update to its website.
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...
JD Supra21d
FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards
The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved ...
Federal agents seize nine pounds of tianeptine at port of Cincinnati
Federal authorities say two shipments containing a deadly, addictive and illegal substance was seized at the port of ...
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Border Patrol agents at CVG intercept nine pounds of unsafe and illegal food additive tianeptine
U.S. Customs and Border Protection (CBP) officers at the Port of Cincinnati seized two shipments on February 7 containing the deadly, addictive, and illegal substance tianeptine. Officers seized the 9 ...