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Selecting and Submitting an ANDA Application

Selecting and Submitting an ANDA Application

The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until an ANDA …

Radhika Rajagopalan

Radhika Rajagopalan works in the pharmaceutical industry and has over 23 years of experience with dosage forms’ CMC sections for both 505(j) and 505 (b2) applications. She is an expert in CMC packages including ADNAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTC ANDAs,...