Botanical Drug Resources

Resources for your further exploration of botanical drug regulations in the US.

Botanical Drug Development

Investigational New Drugs (IND's)

New Drug Applications (NDA's)

Orphan Drug Designation

Chemistry, Manufacturing, and Controls (CMC)

Clinical Trials- Botanical Drugs

Good Manufacturing Practices - 21 CFR 211

Botanical Drug Development

FDA Guidance for Industry :

Botanical Drug Development

Regulatory submissions

Investigational New Drug Applications (IND’s)

References

Content and Format of IND’s for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products

References

Exploratory IND Studies

References

INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information

References

Investigational New Drug Applications (INDs)- Determining Whether Human Research Studies can be Conducted Without an IND

References

FDA Guidance for Industry: Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

New Drugs Applications

New Drug Applications (NDA’s)

References

FDA Guidance for Industry: Formatting, Assembling and Submitting New Drug and Antibiotic Applications (1997)

References

FDA Guidance for Industry: Format and Content of the Microbiology Section of an Application

References

FDA Guidance for Industry: Format and Content of the Clinical and Statistical Sections of an Application

References

FDA Guidance for Industry: Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application

References

FDA Guidance for Industry: Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application

References

FDA Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

References

FDA Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs and General Considerations

Orphan Drug Designation

References

FDA: Clarification of Orphan Drug Designation of Drugs and Biologics for Pediatrics

References

FDA: Meetings with the Office of Orphan Products Development

References

FDA: Rare Diseases: Common Issues in Drug Development

Chemistry manufacturing and controls

Chemistry Manufacturing and Controls (CMC)

References

FDA Guidance for Industry: Process Validation: General Principles and Practices

References

FDA Guidance for Industry: Submission of Quality Metrics Data

References

FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information

References

FDA Guidance for Industry:

Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry

References

ICH: Q1A (R2) STability Testing of New Drug Substances and Products

References

ICH: Q1E Evaluation of Stability Data

References

ICH: Q2(R1) Analytical Validation

References

ICH: Q3A (R2) Impurities in New Drug Substances

References

ICH: Q3B(R2) Impurities in New Drug Products

References

ICH: Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

References

ICH: Q8(R2) Pharmaceutical Development

Good Agricultural and Collection Practices

Good Manufacturing Practices (21 CFR 211)

References

FDA Guidance for Industry: WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants

FDA Guidance for Industry: Guideline on the Preparation of Investigational New Drug Products

FDA Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs

FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements

FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

References

International Council for Harmonisation (ICH)

ICH: Q7- Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

References

International Council for Harmonisation (ICH)

ICH: Q8(R2) Pharmaceutical Development

References

International Council for Harmonisation (ICH)

ICH: Q10 Pharmaceutical Quality System

Clinical Trials

References

FDA Guidance for Industry: Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

References

FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics

References

FDA Guidance for Industry: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

References

FDA Guidance for Industry: Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products

References

FDA Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers

References

FDA Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials

References

FDA Guidance for Industry: Establishment and Operation of Clinical Trial Data Monitoring Committees

References

ICH: E3 Clinical Study Reports

References

ICH: E6(R2) Good Clinical Practice

References

ICH: E8 General Considerations for Clinical Trials

References

ICH: E9(R1) Statistical Principles for Clinical Trials

References

ICH: E10 Choice of Control Group and Related Issues in Clinical Trials