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The VPAT was originally designed as a tool for vendors to document product compliance to Section 508 and facilitate government market research on ICT with accessible features. Many people started to call the completed document a "VPAT" but the wider procurement community would prefer to call it a product Accessibility Conformance Report, or ACR.
Under Title III of the ADA, all new construction (construction, modification or alterations) after the effective date of the ADA (approximately July 1992) must be fully compliant with the Americans With Disabilities Act Accessibility Guidelines (ADAAG) [13] found in the Code of Federal Regulations at 28 C.F.R., Part 36, Appendix A.
Enforcement programs streamlined by contingencies of FDA field activities [5] [6] Establishment of Office of Criminal Investigations; New drug approval process funding by prescription drug user fee [7] [8] Progressive domestic and imports investigation programs by FDA [9] Proposed rule for regulation of tobacco by U.S. FDA [10] [11] [12]
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
On April 24, 2024, the Federal Register published the Department of Justice’s (DOJ) final rule updating its regulations for Title II of the Americans with Disabilities Act (ADA). The final rule states that the Web Content Accessibility Guidelines (WCAG) Version 2.1, Level AA is the technical standard for state and local governments’ web ...
FDA posts status of the review as either without further questions (as a position of "no objection") or the petition is withdrawn by the applicant. [ 4 ] For substances used in food prior to January 1, 1958, a grandfather clause allows experience based on common use in food to be used in asserting an ingredient is safe under the conditions of ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...