Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 41
Resources: Guidelines
T
he regulatory nature of the bio/pharma-
ceutical industry requires close adher-
ence to regulations, good manufacturing
practices, and guidelines. The websites of
regulatory authorities provide information to assist
drug development and manufacturing organiza-
tions in navigating the regulatory process. This sec-
tion lists information sources to key topics; click the
appropriate link to access the online information.
The following pages list key guidance documents
from FDA, European Medicines Agency (EMA), the
World Health Organization (WHO), and the Inter-
national Council for Harmonisation (ICH)*.
US Food and Drug Administration Resources
FDA Human Drugs
FDA Animal and Veterinary Drugs
FDA Vaccines, Blood, and Biologics
FDA Cellular & Gene Therapy Products
FDA Compliance Actions and Activities
FDA Development & Approval Process
FDA Drug Shortages
FDA Guidance Documents
FDA New Drug Approvals
FDA Regulatory Science
FDA Rules and Regulations
FDA Warning Letters
US Regulations
Code of Federal Regulations, Title 21, Food and
Drugs
Federal Register Notices Pertaining to Drugs
Select FDA Guidance Documents
• Advancement of Emerging Technology Appli-
cations for Pharmaceutical Innovation and
Modernization Guidance for Industry (PDF)
• Analytical Procedures and Methods Validation
for Drugs and Biologics (PDF)
• Assay Development and Validation for Immu-
nogenicity Testing of Therapeutic Protein
Products, Draft Guidance (PDF)
• CMC Postapproval Manufacturing Changes
To Be Documented in Annual Reports (PDF)
• Comparability Protocols for Human Drugs
and Biologics: Chemistry, Manufacturing, and
Controls Information Guidance for Industry,
Draft Guidance (PDF)
• Contract Manufacturing Arrangements for
Drugs: Quality Agreements (PDF)
• Current Good Manufacturing Practice for
Phase 1 Investigational Drugs (PDF)
• Data Integrity and Compliance With Current
Good Manufacturing Practice Guidance for
Industry (PDF)
Resources, Guidelines,
and Guidance Documents
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