Title 21 - Food & Drugs Part 312 - Investigational New Drug Application (IND) and under this part [ 21 CFR 312 Subpart D ] include both those applicable to an.
Process for Handling Referrals to FDA Under 21 CFR 4 FDA adopted 21 CFR Part 50 Subpart D, “Additional Safeguards for Children in Clinical. 38 .. The considerations under FDA's IND regulations (see 21 CFR Part 312) and IDE.
Under 21 CFR Part 312 Investigational New Drug (IND) Application . Retaining adequate records under 21 CFR 312, Subpart D, for two years.
21 cfr 312 subpart d - lifenews
A to Z Index. Subpart E--Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses. Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests. Note: If you need help accessing information in different file formats, see. Training and Continuing Education. FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems bioequivalence regulations to correct a typographical error. More limitations on accuracy are described at the GPO site.
Quick Links: Skip to main page content. Cornell University Law School Search Cornell. Links on this page:. Federal Rules of Appellate Procedure. It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly.