Ben Hargreaves covers how the US FDA has updated its guidance documents to demand that trial sponsors must make diversity a part of their planning. Clinical trials have long had a problem with ...

The FDA has published its long-awaited ... The draft guidance spells out the way trial sponsors should structure diversity action plans (DAPs) to increase enrolment of subjects from historically ...

The removal of the FDA’s draft guidance on clinical trial diversity from the agency’s website, followed by its reappearance — with a note that the agency and administration “reject” it ...

The US Food and Drug Administration (FDA), for example, is currently working on new guidance that outlines how companies must ensure diversity in clinical trial research. Cecilia Tran-Muchowski, ...

3 In June 2024, the FDA addressed this in a draft guidance ... “I believe in common sense, and I believe in clinical trial diversity,…so I believe if you’re going to [extrapolate] results ...

The removal of pages linking to diversity ... (FDA’s) and National Institute of Health (NIH) websites covering diversity were ...

CERo Therapeutics received FDA approval for its IND CMC amendment, crucial for starting CER-1236 patient dosing. The phase 1 trial will assess CER-1236's safety and efficacy in relapsed or refractory ...

“Receiving the FDA’s clearance to proceed with our Phase 2 clinical trial for TPST-1495, our second clinical program, in FAP marks an important step forward in developing new treatment options ...

FDA lifts hold on vTv's Phase 3 trial for cadisegliatin in type 1 diabetes, allowing the company to proceed with a shortened six-month study vTv plans to amend the trial protocol, reducing its ...

The FDA’s IND clearance marks a significant milestone ... The IND submission included interim clinical data from the Heart-2 Phase 1b clinical trial’s dose-escalation phase, which is ...