9 articles
The US FDA has reportedly shelved its fast-track drug review voucher program initiated during the Trump administration amid concerns over political influence and leadership instability. While some dru
The Trump administration is advancing a policy permitting specialty pharmacies to compound specific unregulated peptide drugs, bypassing traditional FDA vetting. This regulatory shift targets a potent
Amid uncertainty over the FDA's next leadership, concerns emerge regarding the influence of its 50 scientific advisory committees on critical health regulations. These panels advise on diverse product
The US FDA requested public input on designing clinical trials for ibogaine, a psychoactive drug potentially treating opioid addiction and PTSD. Comments are due by Nov. 20 regarding safety, dosing, a
The US FDA proposed converting its voluntary GRAS notification program into a mandatory requirement for food companies. Firms must now notify the agency when determining substances are generally recog
The FDA plans to establish allowable PFAS levels in bottled water following EPA updates on drinking water limits, despite rejecting a specific petition. This regulatory move aims to align bottled wate
The FDA confirmed trace heavy metals exist in various tampon brands but stated release levels during use pose no health risk. The study identified 19 metals potentially absorbed from soil or added via
BIO CEO John Crowley urges the FDA to standardize drug application reviews to reduce uncertainty, particularly for rare diseases, as part of broader efforts to accelerate clinical trials and maintain
FDA Commissioner Dr. Marty Makary resigned amid political pressure, triggering an initial biotech rally. Analysts warn the leadership vacuum may delay drug approvals and increase market volatility.
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