Source: https://www.law.cornell.edu/cfr/text/16/1702.8
Timestamp: 2015-09-05 17:33:48
Document Index: 420858048

Matched Legal Cases: ['art 1702', '§ 1702', 'art 312', 'art 314', 'art 1702', '§ 1269', '§ 1471', '§ 1472', '§ 2079']

16 CFR 1702.8 - Human experience data. | US Law | LII / Legal Information Institute
CFR › Title 16 › Chapter II › Subchapter E › Part 1702 › Section 1702.8 16 CFR 1702.8 - Human experience data.
§ 1702.8
Human experience data.
Reports from Poison Control Centers,
Reports of adverse reactions relative to the product that have been submitted to the company by physicians, hospitals, consumers, and other sources,
Extensive searches of the medical, pharmacological, and toxicological literature, and
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 2015-01-01.No entries appear in the Federal Register after this date, for 16 CFR Part 1702.
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.United States CodeU.S. Code: Title 15 - COMMERCE AND TRADE§ 1269 - Regulations§ 1471 - Definitions§ 1472 - Special packaging standards§ 2079 - Transfers of functions