Documents For Comments

ADDITIONAL STRENGTH BIOWAIVER APPLICATION FORM1 – For Comments

Closing date : 12 October 2020

BIOEQUIVALENCE TRIAL INFORMATION FORM1 – For Comments

Closing date : 12 October 2020

BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER APPLICATION FORM1 – For Comments

Closing date : 12 October 2020

SUMMARY OF CRITICAL REGULATORY ELEMENTS (SCoRE) DOCUMENT – For Comments

Closing date : 12 October 2020