Title 21 food and drugs chapter i food and drug administration, department of health and human services continued subchapter d drugs for human use part 312 investigational new drug application subpart b investigational new drug application ind section 312. Title 21 food and drugs chapter i food and drug administration, department of health and human services continued subchapter. Cfr, part 312 cfr code of federal regulations title 21. The general principle underlying the conduct of such meetings is that there should be free, full. Dea217f rin 1117aa60 electronic orders for controlled substances. In the official paper bound version and the official pdf versions of 2007 edition. Sample size calculations in clinical research pdf free download. Part 312 investigational new drug application subpart b investigational new drug application ind section 312. This white paper provides a concise look at how smartsolve can help your organization comply with the various subparts of 21 cfr part 820. Title 21 part 312 title 21 chapter i subchapter d part 312 electronic code of federal regulations e cfr. Start studying 21 cfr 312 investigational new drug applications. The code of federal regulations cfr annual edition is the codification of the general and permanent rules published in the federal register by the departments and agencies of the federal government produced by the office of the federal register ofr and the government publishing office download the code of federal regulations in xml download the electronic code of federal regulations in. The information on this page is current as of april 1 2019 for the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr.
The ultimate guide to 21 cfr part 11 7 persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. You can download the entire cfr index and finding aids volume or just the. Monthly title and part user viewing data for the ecfr is available for download in csv format. Subchapter d drugs for human use part 312 investigational new drug application subpart b investigational new drug application ind. The general principle underlying the conduct of such meetings is that there should be free. References in this part to regulations in the code of federal regulations are to chapter i of title 21, unless otherwise noted. References in this part to regulations in the code of federal regulations are to chapter i of title 21. Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Free of charge, country the national health service in part viiib of drug tariff.
Code of federal regulations govinfo government publishing office. Billing code 441009p department of justice drug enforcement administration 21 cfr parts 5, 11 docket no. Central banks with a greater responsibility for financial stability may also use interest rates more actively to safeguard it. Adverse event cfr code of federal regulations title 21. Data retention when subjects withdraw from fdaregulated clinical trials. Guidance for sponsors, clinical investigators, and irbs. The code of federal regulations cfr annual edition is the. The following definitions of terms apply to this section. Provides the text of the code of federal regulations cfr.
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