Drug, Biologic and Device Regulatory Pathway Flashcards
21 CFR 314.92
Drug products for which abbreviated applications may b submitted
Food and Drug Administration Safety and Innovation Act (Jan 2012)
a
21 CFR 314.93
Petition to request a change from a listed drug
21 CFR 314.54
Procedure for submission of an application requiring investigations for approval of a new indication for, or other change form, a listed drug
12 CFR 310.3
Definitions and interpretations (new drugs) - define a drug as “a product used in diagnosing, curing, mitigating, treating or preventing disease or affecting a structure or function of the body.”
21 CFR 316
Orphan Drugs - affects fewer than 200K people in the US. Extends marketing exclusivity 7 years, has an accelerated approval pathway for “breakthrough therapies”. Tax credit for qualified research expenses during development.
21 CFR 312
Subpart E Dugs intended to treat life-threatening and severely debilitating illnesses
21 CFR 314
Subpart H Accelerated approval of new drugs for serious or life-threatening illnesses
21 CFR 312
Investigational New Drug Application
21 CFR 312.50
General responsibilities of sponsors
21 CFR 312.60
General responsibilities for investigators
21 CFR 312.33
Annual reports (IND)
21 CFR 312.32
IND safety reports
21 CFR 312.23
IND content and format
21 CFR 312.38
Withdrawal of an IND