Author(s): Muhammad Asif Rasheed
Author(s): Mamatha Dereddy*
Author(s): Aseel Bin Sawad and Fatema Turkistani
Author(s): Sameh Mohamed Abouzeid
Author(s): Lalitha Padala*
Author(s): Fulmer Shealy V.K
Author(s): US Food and Drug Administration (FDA) exercises flexibility in the requirement that new drugs provide substantial evidence of benefit under the Food, Drug and Cosmetic Act. Provisions in law and policy provide numerous exceptions to the historical scientific standard of 2 or more controlled clinical trials demonstrating statistically significant evidence of benefit.