Fda drugs 21 cfr 312 pdf

Current good manufacturing practice cgmp regulations fda. Federal register importation of prescription drugs. Between fiscal years 1994 and 1997, fda received nearly 1,800 export requests under the 312. Act means the federal food, drug, and cosmetic act secs.

Department of health and human services food and drug. Amended ind safety reporting requirements under 21 cfr part 312 goals. Regulatory hearing before the food and drug administration 21 cfr part 16. The firm should submit the ind before importing the drug product.

A sponsor shall ship investigational new drugs only to investigators participating in the investigation. There are nine subparts all explaining different topics around managing drug products before the required fda. Investigational new drug application 21 cfr part 312 applications for fda approval to market a new drug 21 cfr part 314 bioavailability and bioequivalence requirements 21 cfr part 320. Investigators wishing to study the use of convalescent plasma in a clinical trial should submit requests to fda for investigational use under the traditional ind regulatory pathway 21 cfr part 312.

Help more about 21cfr code of federal regulations title 21, volume 5 revised as of april 1, 2019 cite. Food and drug administration investigational new drug. Submit all postmarketing final reports to this bla. Drug, and cosmetic act to facilitate the development of drugs for rare diseases and conditions in pdf. The program for exporting investigational new drugs is commonly known as the 312 program because the regulation pertaining to the program is located in part 312 21 cfr part 312.

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug. Fda will notify the sponsor in writing of the date it receives the ind. If an investigational new drug is a substance listed in any schedule of the controlled substances act 21 u. Subpart iexpanded access to investigational drugs for treatment use. 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. Electronic code of federal regulations e cfr title 21 food and drugs rules and regulations. Barriers to communications under current fda regulations 21 c. Safety assessment for ind safety reporting guidance for. Title 21 part 312 title 21 chapter i subchapter d part 312 electronic code of federal regulations e cfr. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the federal food, drug, and cosmetic act or to the licensing provisions of the public health service act 58 stat. Fda s portion of the cfr is in title 21, which interprets the federal food, drug and cosmetic act and related statutes, including the public health service act.

In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Safety assessment for ind safety reporting guidance for industry. The code of federal regulations title 21 contains the codified federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and. Practice regulations and investigational new drugs text pdf january 17, 2006. References in this part to regulations in the code of federal regulations are to chapter i of title 21. List numbers of all investigational new drug applications 21 cfr part 312, new drug applications 21 cfr part 314, drug master files 21 cfr part 314. Code of federal regulations title 21 food and drugs fda. This guidance applies to clinical investigations conducted under 21 cfr part 312 investigational new drug applications or ind regulations. Ensuring the safety of clinical trials investigations. Drugs the center for drug evaluation and research cder ensures that safe and effective drugs are available to improve the health of the people in the united states. Expanded access to investigational drugs for treatment use. The code of federal regulations cfr is a codification of the general and permanent rules published in the federal register by the executive departments and agencies of the federal government. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr.