The Investigational New Drug (IND) and New Drug ...

Feb 02, 1998 · The Investigational New Drug (IND) and New Drug Application (NDA) Process Susan Honig, MD ... and strength of the drug • Impurities, sterility • Product consistency. Requirements for a New IND: ... • 3 products converted from accelerated approval to full approval – Taxotere, with expansion of its indication ...

  Product, Drug, Impurities, New drugs, 3 products