FDA’s Woodcock Urges Patient Groups To Take Lead To Speed Regulatory Process, Development
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Medical and patient communities can help make up for FDA’s resource gaps by developing PRO standards and benefit-risk frameworks for specific diseases, FDA drug chief says.
You may also be interested in...
20 Is The Loneliest Number: FDA Disease Meeting Schedule Leaves Some Worried About Exclusion
Conflict among groups with conditions both included and not included in the preliminary list of public meeting topics prompts FDA to reiterate that the diseases will be selected because better clinical measures are needed, not because the agency will prioritize them over others.
Value-Based Pricing Bill with New Protections for Medicare and Medicaid Clears House Panel
Energy and Commerce Committee made some changes to a Trump-era regulation designed to make it easier for manufacturers to enter into value-based drug pricing contracts with commercial payers to limit unintended consequences for Medicaid and Medicare, but most Democrats say the tweaks don’t outweigh the harms of codifying the regulation.
Pfizer’s RSV Vaccine: US FDA Panel Wants Robust Safety Program With Public Accountability
Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.