On request, fda will advise on the applicability of this part to a planned clinical investigation. Chemistry, manufacturing, and control cmc information. Dec 08, 2016 investigational new drug safety reports 21 cfr 312. Understanding fda regulatory requirements for investigational new. Investigational new drug applications prepared and. Regulations, policies, and guidance national institute on. The code of federal regulations cfr annual edition is the codification of the general and. Cfr code of federal regulations title 21 food and drug. 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. 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. Electronic code of federal regulations e cfr title 21 food and drugs. Chemistry, manufacturing, and control cmc information for. 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. The following fda human subject research regulations apply to the irb and to university.
Department of health and human services food and drug administration investigational new drug application ind note. I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the studyies are informed about their obligations in meeting the above commitments. Subpart e drugs intended to treat lifethreatening and severelydebilitating illnesses sec. May 24, 2010 amended ind safety reporting requirements under 21 cfr part 312 goals. Irb must concur with exemption determination by fda. Guidance on cmc for phase 1 and phases 23 investigational. Cfr code of federal regulations title 21 us food and drug. Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following. Apr 01, 2020 if an investigational new drug is a substance listed in any schedule of the controlled substances act 21 u. I agree to report to the sponsor adverse experiences that occur in the course of the investigations in accordance with 21 cfr 312. Details of the 34 informational content of an ind as well as information needed to complete required forms also. A sponsorinvestigator assumes both investigator and sponsor responsibilities as outlined in the fda.
Ind is synonymous with notice of claimed investigational exemption for a new drug fda 21 cfr 312. Fda 21 cfr 314 application for fda approval to market a. Information amendments ia a a sponsor shall report in an information amendment essentialinformation on the ind examples of information requiring ia include. Concurrent with marketing approval, fda may seek agreement from the sponsor to conduct certain postmarketing phase 4 studies to delineate additional information about the drugs risks, benefits, and optimal use. No investigator may participate in an title 21, code of federal regulations cfr part 312 see instructions on reverse side.
For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Depending on the specific study, additional documents may be. Subpart b investigational new drug application ind 312. Start letter should clearly define reporting requirements best practice to have investigator. If irb disagrees with sponsor determination must refer to fda. Investigational new drug applications prepared and submitted. Requirements for investigational new drug ind mass general.
The table below lists the individual parts and volumes of this title by federal agency or regulatory entity to which the laws or regulations included in that volume pertain. Investigational new drug applications indsdetermining whether. Part 11 falls under chapter i, which applies to the food and drug administration fda and is largely based on the food, drug, and cosmetic act from 1938. Onsite documents listed in the right column correspond to the regulations written in 21 cfr 312 drugs, biologics and the institutional policy and can provide evidence that the sponsorinvestigator has fulfilled hisher responsibilities. No drug biologic may be shipped or clinical investigation begun until an ind for that investigation is in effect 21 cfr 312. Cmc requirements for an investigational new drug application. Nov 10, 2020 fda may, on its own initiative, issue guidance on the applicability of this part to particular investigational uses of drugs. Public law 97414 to amend federal food, drug, and cosmetic act to facilitate the development of drugs for rare diseases and conditions in pdf summary of h.
If an investigational new drug is a substance listed in any schedule of the controlled substances act 21 u. Title 21 food and drugs chapter i food and drug administration, department of health and human services continued subchapter. 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 illegal drugs. An adverse event occurring in the course of the use of a drug product in professional practice. Federal register investigational new drug safety reporting. The sponsor shall notify the fda and all participating investigators in a written ind safety report, as specified in fda 21 cfr 312. There are nine subparts all explaining different topics around managing drug products before the required fda approval of that product. 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. Regulations, policies, and guidance national institute. The following definitions of terms apply to this section. The sponsor, in turn, is required under 21 cfr 312.
Title 21 of the code of federal regulations wikipedia. Electronic code of federal regulations e cfr title 21. Therefore, to conduct drug studies, an investigator must comply with fda requirements. Definitions and standards for expedited reporting pdf, 184 kb ich guidance fda regulation 21 cfr 312. Overview of fda regulations, information sheets and.
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