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If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42. An IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use," per 21 CFR 312.6
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 ...
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
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
In addition, federal offices of inspectors general employ forensic auditors, or "audigators", evaluators, inspectors, administrative investigators, and a variety of other specialists. Their activities include the detection and prevention of fraud, waste, abuse, and mismanagement of the government programs and operations within their parent ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
Under 28 CFR 600, [6] Robert Mueller was appointed Special Counsel in 2017 to investigate possible interference by the Russian government in the 2016 presidential election, including a possible criminal conspiracy between Russia and the presidential campaign of Donald Trump. [7] The investigation was officially concluded on March 22, 2019.
DCSA Industrial Security Representatives, Counterintelligence Agents, Background Investigators, and Information System Security Professionals are credentialed Special Agents. DCSA also uses a number of contract investigators and staff to help support DCSA's various missions.