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The Americans with Disabilities Act of 1990 or ADA (42 U.S.C. § 12101) is a civil rights law that prohibits discrimination based on disability. It affords similar protections against discrimination to Americans with disabilities as the Civil Rights Act of 1964 , [ 1 ] which made discrimination based on race , religion , sex , national origin ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The ADA Amendments Act of 2008 (Public Law 110–325, ADAAA) is an Act of Congress, effective January 1, 2009, that amended the Americans with Disabilities Act of 1990 (ADA) and other disability nondiscrimination laws at the Federal level of the United States. [1]
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)
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 ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
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 ...