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Home » FDA Manual of Policies and Procedures Updates ANDA Suitability Petitions
FDA Manual of Policies and Procedures Updates ANDA Suitability Petitions
The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter.