The guidance, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food,Drug, and Cosmetic Act, provides information on implementation of the new requirements for certain postmarketing studies and clinical trials for prescription drugs approved under the FD and C Act and biological products approved under the Public Health Service Act. It also provides a description of the types of postmarketing studies and clinical trials that will generally be required under the new legislation.
Post Marketing.pdf (56.5 KB)