To Prevent Drug Shortages, Don't Look To Inspections, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency maintains its inspection policy does not cause or prevent shortages.
You may also be interested in...
Drug Shortages: FDA Says Market Must Reward Production Quality
FDA officials state in journal article that manufacturers are not incentivized to ensure quality and base competition entirely on price.
FDA And Generic Drug Quality: Turning Point, Or Precipice?
OGD Director Geba says generic manufacturers still suffer from extensive quality problems, but GPhA officials argue the industry is doing fine and communications with the agency need to be more uniform.
FDA Spending Less Time On INDs, More On NDAs and BLAs
Five-year averages used in calculations of FY 2013 user fee rates show a decrease in time devoted to INDs and an increase in time spent on NDAs and BLAs. The average submission volume in both categories still increased.