USA – FDA finalizes guidance on use of human factors studies in combination product...
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the...
USA – FDA draft guidance focuses on postapproval trial diversity data
Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs...
USA – FDA finalizes guidance on standards for tracing products through supply chain
The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email...
USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...
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The US Food and Drug Administration (FDA) just published draft guidance to assist sponsors determine the appropriate supplement category for biosimilar applications and its...
