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Guidance for Industry. [23] This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.
By writing advisory circulars, the FAA can provide guidance for compliance with airworthiness regulations, pilot certifications, operational standards, training standards, and any other rules within the 14 CFR Aeronautics and Space title, aka 14 CRF or FARs. The FAA also uses advisory circulars to officially recognize "acceptable means, but not ...
This template generates a link to a section of the U.S. Code of Federal Regulations (CFR) Template parameters [Edit template data] This template prefers inline formatting of parameters. Parameter Description Type Status Title 1 Title within the CFR Number required Part 2 Part of within CFR Number suggested Section 3 Section within the CFR String suggested Clause 4 Clause within the CFR, with ...
Administrative guidance (行政指導, gyōsei shidō) is a Japanese government practice defined under Article 2 of the Administrative Procedure Act of 1993 as "guidance, recommendations, advice, or other acts by which an Administrative Organ may seek, within the scope of its duties or affairs under its jurisdiction, certain action or inaction on the part of specified persons in order to ...
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
The removal of the word 'Regulatory' was also a recognition that many Government burdens on business, the third sector and public bodies were not always implemented as legislation or regulations e.g. codes of practice, reporting requirements or funding guidance, and that the impacts of these measures also needed to be assessed. [citation needed]