Pink Sheet Podcast: Coronavirus Vaccine Trial Designs, US FDA Approval Trends While Teleworking, Price Increases And The Part D Donut Hole Fix
Executive Summary
Pink Sheet reporters and editor discuss CBER Director Marks’ ideas for coronavirus vaccine clinical trials, changes in FDA approval volume under the teleworking order, and a study of the Medicare Part D donut hole fix.
You may also be interested in...
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.
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.
Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length
Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.