Search results
Results from the WOW.Com Content Network
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...
Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...
FDA: Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [40] provides recommendations for the development of drugs and therapeutic biologics regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Specifically, this guidance ...
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]
FDA accepts Pfizer's (PFE) NDA for ritlecitinib for treating severe alopecia areata. The EMA also accepts the MAA for a similar patient population.
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 ...