USFDA GUIDElINES (Generic Drug )

180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I)


Abbreviated New Drug Applications: Impurities in Drug Products


ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I)


ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I)


ANDA Submissions – Prior Approval Supplements Under GDUFA (DRAFT)


ANDA Submissions – Amendments and Easily (DRAFT)


ANDA Submissions — Refuse-to-Receive Standards


Handling and Retention of Bioavailability and Bioequivalence Testing Samples (I)


Revising ANDA Labeling Following Revision of the RLD Labeling (I)


Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules


Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (I)


Variations in Drug Products that May Be Included in a Single ANDA (I)


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