GDUFA Plus One: Stakeholders, FDA Confident As Review Goals Near
Review metrics go into effect in another year, but times continue to increase; FDA and others still believe they are well on their way to meeting the generic drug user fee goals.
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Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.
Under GDUFA, drug master files must pass a completeness assessment before they can be referenced in an ANDA. Sponsors should coordinate better with DMF holders to assure that FDA has adequate review time.
Generic User Fee Agreement Includes FDA Pledge To Determine Best Use Of Foreign Regulator Inspections
Draft commitment letter could be first step down globalization road in which FDA relies more on foreign governments to boost manufacturing oversight.