US FDA Draft Guidance Tells Medtech How To Recruit, Report Trial Subpopulations
This article was originally published in SRA
Executive Summary
Medical device makers should be prepared to identify and consider specific differences between patients of varying ages, races and ethnicities, and incorporate queries about subgroups into clinical trial designs and reports supporting 510(k) and premarket approval (PMA) submissions, the US Food and Drug Administration says in a guidance 1,2.
You may also be interested in...
US FDA Outlines Format For Race, Ethnicity Data Collection
The guidance document tells sponsors to ask about ethnicity before race, and provides suggested wording. It updates a 2005 guidance.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.