FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development 242

Development Bioequivalency Generic Drugs Production 242

Drug Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

Production 52

Production Bioequivalency In-Vivo In-Vitro 52