Human experience data constitutes the primary criterion used by the Commission in evaluating petitions for exemptions. Petitions shall therefore include a compilation of all reasonably available reports pertaining to human use of the particular substance, including the product brand as well as generic equivalents and involving adverse reports of personal injury, illness, and significant allergenicity. Such information in children is of particular importance in evaluating exemption requests. However, similar data in adults shall also be submitted if available. Human experience data may be obtained from such sources as:
(a) Reports from Poison Control Centers,
(b) Reports of adverse reactions relative to the product that have been submitted to the company by physicians, hospitals, consumers, and other sources,
(c) Extensive searches of the medical, pharmacological, and toxicological literature, and
(d) For drugs, where the human experience data submitted is based on data required by FDA to be compiled for an Investigational Exemption for a New Drug (IND), 21 CFR part 312, or a New Drug Application (NDA), 21 CFR part 314, a summary of the relevant data should be provided. The entire NDA and IND material need not be submitted.
Title 16 published on 2013-01-01
no entries appear in the Federal Register after this date.
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.