Bureau of Drugs

The U. S. Antibiotics Standards Research Group (USASRG) is an ad hoc collaboration of antibiotics researchers at the U S. Food and Drug Administration. Contributors to this monograph from the Bureau of Drugs include T. Alexander, R. Barron, V. Folen, K. Furnkranz, G. Mack (Baltimore District), M. Maienthal, G Mazzola (Bureau of Foods), G. Schwartzman, G Selzer, E. She min, J. Taylor. L. Wayland. and J. Weber. [Pg.101]

FD C Yellow No. 5 Aluminum Lake, in nail-care products, 7 853 FDA Bureau of Drug Abuse Control,... [Pg.348]

The FDA s Bureau of Drugs requested a for-cause inspection of the manufacturer s laboratories to determine the cause and extent of the discrepancies. A for-cause inspection is one initiated at the request of an agency unit when there is reason to suspect a problem in an FDA-regulated product. The authority to make for-cause inspections is a general one imder the FFDCA, but one that had rarely been apphed to animal laboratories. [Pg.13]

Significant improvements have been made in time-release formulation in the last several decades. fThe Bureau of Drugs was the predecessor of the Center for Drug Evaluation and Research. [Pg.40]

Bernard T. Loftus Bureau of Drugs, U.S. Food and Drug Administration, Washington, D.C., U.S.A. [Pg.15]

The Bureau of Biologies is merged with the Bureau of Drugs to... [Pg.7]

Bureau of Drug and Medical Devices Registration (BODMDR) Regulatory Requirements and Procedures Future Trends About the Author... [Pg.9]

BUREAU OF DRUG AND MEDICAL DEVICES REGISTRATION (BODMDIQ... [Pg.470]

Bureau of Drug Quality Control and Research Management... [Pg.472]

Clinical studies in China may only be carried out after an application with supporting data, partly equivalent to those for a marketing authorization in many other countries, and are approved by the Bureau of Drug Policy and Administration, Ministry of Public Health. The application must be in accordance with the provisions of the Rules Governing the Approval of Clinical Trial of Foreign Drugs, and the studies must be conducted in compliance with these rules. [Pg.668]

Within 30 days of approval of a clinical trial application, the medical institution in charge must submit a detailed clinical trial protocol to the Bureau of Drug Policy and Administration, with copies to the central Committee of Drug... [Pg.668]

Evaluation and the regional Bureau of Public Health concerned. If no opinion on the draft protocol is expressed by the Bureau of Drug Policy and Administration after 40 days, the medical institution may start the clinical trial. [Pg.668]

Address for documentation Laws and Regulations, Bureau of Drugs Policy and Administration, Ministry of Public Health, No. 44 Houhai Beiyuan, Beijing, China [Tel. +86 (1) 401 2873 Fax +86 (1) 401 2870],... [Pg.671]

All pharmaceutical manufacturers and medical institutions are required by law to report any serious ADRs to the Bureau of Drug Policy and Administration or to regional competent authorities. There are central and regional ADR Monitoring Centres associated with the central and regional Health... [Pg.673]

Unable to attend Ms Metta Treebamroong, Bureau of Drug and Narcotics, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand. [Pg.475]

The FDA s Bureau of Drugs requested a for-cause inspection of the manufacturer s laboratories to determine the cause and extent ofthe discrepancies. A for-cause inspection... [Pg.2]

Once the decision to establish GLP regulations had been made, a subcommittee was appointed to draft the regulations. This subcommittee was composed of individuals representing all the FDA bureaus and a variety of scientific disciplines. The subcommittee began its work with a rough draft that had already been prepared by personnel in the Bureau of Drugs. This early draft had used two independent, unsolicited sets... [Pg.6]

FDA Bureau of Drug Abuse Control and the Treasury Department s Bureau of Narcotics are transferred to the Department of Justice to form the Bureau... [Pg.686]

To take the Bureau of Drugs as an example, there is an Office of Scientific Evaluation with divisions formed along pharmacologic lines such as the Division of Neuropharmacological Drugs, the Division of Cardiopulmonary-Renal Drugs, and the Division of Metabolic and Endocrine Drugs an Office of Compliance an Office of Pharmaceutical Re-... [Pg.256]

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