Drug Compliance Terminology
- Abbreviated New Drug Application (ANDA)
- Accelerated Drug Development/Review
- Active Ingredient
- Allergenics
- Bioavailability
- Bioequivalence
- Biological Product
- Biologics License Applications (BLA) Process
- Biosimilar
- Blood & Blood Products
- Cellular and Gene Therapy Products
- Clinical Trial Investigator
- Clinical Trial Phase 1 Studies
- Clinical Trial Phase 3 Studies
- Clinical Trial Phases
- Clinical Trials
- Clinical Trial Sponsor
- Clinical Trial Sponsor Investigator
- Clinical Trial Subject
- Contract Research Organization (CRO)
- Current Good Manufacturing Practice (CGMP)
- Dietary Supplements
- Generic Drug Approval
- Generic Drugs
- Good Clinical Practice
- Independent ethics committee (IEC)
- Informed Consent
- Institutional Review Boards
- Investigational New Drug (IND) Application
- New Drug Application (NDA)
- New Drug Application - CDR Review
- New Drug Application - Labeling Review
- New Drug Application Microbiology Review
- New Drug Application Refuse to File Letter
- New Drug Application - Statistical Review
- New Drug Development - Biopharmaceutical Review
- New Drug Development - Chemistry Review
- New Drug Development - Clinical Hold Decision
- Orphan Drug Act
- Orphan Drugs
- OTC Drug Monograph
- Pharmaceutical Equivalents
- Pharmacovigilance
- Postmarketing Clinical Trials
- Pre-Clinical Research
- Prescription Drug User Fee Act (PDUFA)
- Therapeutic Biological Product
- Therapeutic Equivalence (TE)
- Tissue & Tissue Products
- Treatment Investigational New Drug
- Vaccines
- Xenotransplantation