In the federal register of june 11, 2010, fda announced the availability of a guidance for industry entitled “bioequivalence recommendations for specific products” that. Fda guidance documents discuss the production, labeling, manufacturing of regulated products and denote fda's current thinking and policy interpretation. Psgs provide recommendations for developing generic drugs and generating evidence to.
We will explore how to interpret these documents as powerful business intelligence, how to integrate them with patent and competitive data to build a winning portfolio strategy,. In the federal register of june 11, 2010, fda announced the availability of a guidance for industry entitled bioequivalence recommendations for specific products that. For complex products approved in new drug applications on or after october 1, 2022, product specific guidance will be issued for 50% of such products within 2 years of.