In the United States, the Orphan Drug Act (ODA) was passed in 1983 to facilitate the development of drugs or biologics that are used for the

Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an accelerated approval under section 233 506(c) of the FD&C Act, 21 CFR 314 (subpart H) for drugs, and 21 CFR 601 (subpart E) for biologics. In these cases, the approval could potentially be granted based on early Phase I/II clinical data. Products falling under subpart H/E are required to have all Advertising and Promotional items reviewed by