Pink Sheet Podcast: COVID-19 Vaccine Distribution Plan And Approval Concerns, Gene Therapy Coaching
Executive Summary
Pink Sheet reporters and editor discuss coronavirus vaccine allocation and prioritization proposals, sponsors submitting before Phase III is completed, and a CBER proposal to create a coaching staff for inexperienced gene therapy sponsors.
You may also be interested in...
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.
FDA’s Authority Looks Safe From Judicial Interference Following Supreme Court Abortion Pill Arguments
The agency's and the pharma industry’s worst fears – that a potential ruling in the mifepristone case might usurp the FDA’s scientific authority and throw the stability of the US drug approval process into question – seem unlikely to materialize as the majority of the Supreme Court justices signal the Alliance for Hippocratic Medicine lacks standing to sue.
US FDA Hopes Food, Inspection Office Reorg Bolsters Innovative Clinical Trial Adoption
Ensuring inspectors understand the innovative trial designs in use before an inspection will be important to increasing industry confidence in their use, CDER Director Patrizia Cavazzoni said.