21 CFR Part310 New Drugs
This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (INDs). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
21 CFR Part 312 Investigational New Drug Application - This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (INDs). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.
21 CFR Part314 Applications for FDA Approval to Market a New Drug
This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.
21 CFR Part 510 New Animal Drugs
This regulation pertains to the protection of the public health on the use of antibiotics in veterinary medical and nonmedical uses. There is particular concern with regard to the potential hazards associated with the extensive use of antibiotics administered to food-producing animals.
21 CFR Part514 New Animal Drug Applications – This law makes provision for new animal drugs or animal feeds which are intended solely for tests in vitro or in animals used only for laboratory research purposes shall be exempt from section 512 (a) and (m) of the act if it is labeled with a warning on the drug that states: Caution. Contains a new animal drug for investigational use only in laboratory research animals or for tests in vitro. Not for use in humans.
21 CFR Part 54 Financial Disclosure by Clinical Investigators
This law states that requests among other things financial disclosures, and other appropriate steps in the design, conduct, reporting and analysis of studies to minimize bias.
21 CFR Part 50 Protection of Human Subjects
This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. This law states additional specific obligations and commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations.
