PHARMACEUTICAL COMPANIES

Regulation of Pharmaceutical Companies

Regulation of Pharmaceutical Companies

01

When the FDA grants approval of drugs or medical devices, the statement only for the use applied for and tested.3, that the test consists of "a strict series of preclinical and clinical trials" to ensure "that the drug or medical device is safe and effective for each of its intended use . "4 In making its decision, FDA is working" substantial evidence "standard.5 As defined in the Federal food, medicines and cosmetics Act and 6 of this standard requires that the data consists of" adequate and well controlled studies, including clinical trials specialists qualified ...