TC Home

The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

Slide background
Slide background
  • April 14, 2020

SILVER SPRING, MD—The FDA published 33 new and 10 revised product-specific guidances, which provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval. Of the 42 guidances, 38 are for products with no approved ANDAs. Guidances for generic products include treatments for ALS, diabetes, HIV, lung cancer, and melanoma.