ANDA Supplement Review Timeline Hinges On Need For Inspection
FDA notes that it may not be evident right away whether an inspection will be required as part of the review.
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Generic drug manufacturers are told by FDA when and how it will accept prior approval supplements under GDUFA.
Acting Deputy Commissioner John Taylor says training often is for reactive work, and FDA must shift to a more proactive strategy and ensure strong regulatory laws, equipment and organizations around the world.
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.