In the News: October Regulatory and Development Updates
Camargo
NOVEMBER 11, 2020
The ANDA application must contain a basis of submission specifying the RLD, and the applicant must show that the proposed generic drug is the same as the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics. Co-Authors: Jenny Fielder.
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