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Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application ; Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. CDER Guidance for Industry.
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
A style guide, or style manual, is a set of standards for the writing and design of documents, either for general use or for a specific publication, organization or field. The implementation of a style guide provides uniformity in style and formatting within a document and across multiple documents.
A code of practice can be a document that complements occupational health and safety laws and regulations to provide detailed practical guidance on how to comply with legal obligations, and should be followed unless another solution with the same or better health and safety standard is in place, [1] or may be a document for the same purpose published by a self-regulating body to be followed by ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange. In November 2000, HL7 published Release 1.0.
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 ...
As part of the Federal E-Government eRulemaking Initiative, the web site Regulations.gov was established in 2003 to enable easy public access to agency dockets on rulemaking projects including the published Federal Register document. The public can use Regulations.gov to access entire rulemaking dockets from participating Federal agencies to ...