FDA GMP Quality Metrics Will Be Industry’s ‘SAT Score’
This article was originally published in PharmAsia News
Executive Summary
Number 2 pencils will not be required, but the U.S. FDA hopes manufacturing reports will make purchasing decisions resemble the college admissions process to some extent.
You may also be interested in...
FDA’s Plaisier: GMP Oversight Must Shift To Outcomes Model
In an interview with “The Pink Sheet,” the Office of Regulatory Affairs chief says she wants to chart her office’s activities based on their effect on public health instead of simply counting outputs like the number of inspections or 483s.
Compounding: Hamburg Asks Purchasers, States To Push Outsourcer Registration
Letters seek help encouraging large-scale compounders to register with the agency as outsourcing facilities; FDA also seeks nominations for its compounding advisory committee.
Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.