Filed December 10, 2010
Pub. L. No. 75-717, 52 Stat. 1040 (1938). The 1962 amendments to the Act changed the definition of “new drug,” adding the requirement that a drug be shown to be effective as well as safe before FDA will approve an NDA.
Filed July 8, 2011
801, Pub. L. No. 75-717, 52 Stat. 1040, 1058 (1938); Pub. Health Sec. & Bioterrorism Preparedness & Response Act of 2002, Pub.