Millions of doughnuts recalled over potential listeria contamination
Be cautious with your favorite pastries this week.
Lipocine (NASDAQ:LPCN) Receives Updated Regulatory Guidance for LPCN 1154
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on delivering therapeutics through effective oral delivery, announced today that it has received revised regulatory guidance for LPCN ...
JD Supra2d
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 ...
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FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
JD Supra3d
FDA Issues Final Guidance Setting Action Levels for Lead in Food Intended for Babies and Young Children
The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for ...
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New FDA initiatives focus on medication safety for pregnant and nursing women
If you are pregnant or nursing, talk with your health care professional about whether to enroll in pregnancy safety or ...
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Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
Please provide your email address to receive an email when new articles are posted on . FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance ...
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The FDA pulls key DEI initiative for cancer studies from its website
The Food and Drug Administration has removed webpages about diversity and inclusion in clinical trials for cancer drugs. The page for Project Equity, a 2021 initiative launched by the FDA's ...