USA – FDA finalizes guidance on real-world evidence in drug approvals
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in...
USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about...
USA – FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants
Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent...
USA – Bacterial endotoxin testing of drugs and biologics in the US: Ensuring patient...
Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – FDA drafts guidance on classification category for biosimilar supplements
The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its...
USA – QTc: FDA proposes labeling for heart drugs with heart rhythm risk
The US Food and Drug Administration (FDA) on Monday issued draft guidance offering recommendations for sponsors to include labeling information on QTc interval prolongation...
USA – FDA sets acceptable intake limits for nitrosamines in drugs
The US Food and Drug Administration (FDA) on Friday issued a final guidance that outlines a framework for predicting the mutagenic and carcinogenic risk...
USA – FDA finalizes guidance on DSCSA waivers, exceptions and exemptions
The US Food and Drug Administration (FDA) recently published a final guidance on its process for granting – or denying – waiver, exceptions and...
USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention...
