Draft Bill’s GMP Shortcut for Shortage Drugs Is Balanced: Expert

April 18, 2012
Drugmakers may soon be able to get critical shortage drugs to market faster with a proposed shortcut for proving manufacturing compliance that’s included in draft legislation to reauthorize the FDA’s user fee programs. To prevent or alleviate shortages of life-sustaining drugs, the HHS secretary may deem major manufacturing changes in compliance with GMPs if a drugmaker can at least implement adequate interim controls and has a plan and enough resources to achieve full compliance. This move presents risks but is generally balanced, industry experts say.
Drug GMP Report