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Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions
§ 360bb - Designation of drugs for rare diseases or conditions
§ 360cc - Protection for drugs for rare diseases or conditions
§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions
§ 371 - Regulations and hearings
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 316 after this date.
The Food and Drug Administration (FDA) is publishing this document to clarify its policy regarding certain aspects of orphan-drug exclusivity. This document is being published because of a recent court decision interpreting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Orphan Drug Act.
The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.