The aim is to make clinical trials more agile without compromising data integrity or participant protections, the agency said.

"A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients," FDA Commissioner Dr. Robert Califf said in a statement. "These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results."

The updates are intended to help enable more efficient clinical trials to facilitate the development of medical products.

The draft guidance is adapted from the International Council for Harmonisation's (ICH) recently updated E6(R3) draft guideline, which was developed to enable the incorporation of rapidly developing technological and methodological innovations into clinical trials.

FDA grants full approval for antiviral pill to treat mild-to-moderate COVID-19 in adults
The U.S. Food and Drug Administration (FDA) on Thursday approved Pfizer’s Paxlovid, an oral antiviral drug, for the treatment of mild-to-moderate COVID-19...

FDA approves first topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa
The U.S. Food and Drug Administration (FDA) said on Friday it has approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for...

FDA approves first drug to treat agitation associated with dementia due to Alzheimer’s
The U.S. Food and Drug Administration (FDA) on Thursday announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment...

Adaptive Biotechnologies, Genentech announce FDA acceptance of investigational new drug application
Adaptive Biotechnologies on Tuesday announced that the U.S. Food and Drug Administration (FDA) has accepted an investigational new drug (IND) application...

FDA approves first respiratory syncytial virus vaccine
The U.S. Food and Drug Administration (FDA) said Wednesday that it has approved the use of GlaxoSmithKline Biologicals’ Arexvy vaccine for respiratory...