Search results
Results From The WOW.Com Content Network
The office's primary duty is the implementation of 45 CFR 46, a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
The EPA sets and enforces standards for air, soil and water quality, evaluates the impact of pesticides and chemical substances, and manages the Superfund program for cleaning toxic waste sites. The Export–Import Bank of the United States (EXIM) is the official export credit agency (ECA) of the United States federal government. Operating as a ...
The procurement requirement is established to ensure that such goods and services are obtained in an effective manner and in compliance with laws and regulations, including the prohibition of conflicts of interest, the fair selection of vendors, provide open and free competition among vendors, etc. [33] The suspension and debarment requirement ...
The Office of Research Integrity (ORI) is a U.S. government agency that focuses on research integrity, especially in health.It was created when the Office of Scientific Integrity (OSI) in the National Institutes of Health (NIH) and the Office of Scientific Integrity Review (OSIR) in the Office of the Assistant Secretary for Health merged in May 1992.
Under the Pandemic and All Hazards Preparedness Act of 2006 (PAHPA) (Pub. L. 109–417 (text)), HHS is the lead agency for the National Response Framework (NRF) for Emergency Support Function 8 (ESF-8). The Secretary of HHS delegates to ASPR the leadership role for all health and medical services support functions in a health emergency or ...