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NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials

Putting Patients First Blog

NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials (PDF) September 26, 2024 The Honorable Robert M. Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. 8 Scott, P.,

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov. If the new clinical study finds that a lower drug dose can achieve similar efficacy, the hope is that this could result in fewer side effects for patients.

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