48 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Resources: Guidelines
T
he regulatory nature of the bio/pharmaceu-
tical industry requires close adherence to
regulations, good manufactuing practices,
and guidelines. The websites of regulatory
authorities provide information to assist drug develop-
ment and manufacturing organizations in navigating
the regulatory process. This section lists information
sources to key topics; click the appropriate link to ac-
cess the online information.
The following pages list key guidance documents
from FDA, European Medicines Agency (EMA), the
World Health Organization (WHO), and the Interna-
tional 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
• Analytical Procedures and Methods Validation
for Drugs and Biologics (PDF)
• Assay Development and Validation for Immu-
nogenicity Testing of Therapeutic Protein Prod-
ucts, Draft Guidance (PDF)
• Assessing User Fees Under the Biosimilar User
Fee Amendments of 2017 Guidance for Industry
(PDF)
• Biosimilars and Interchangeable Biosimilars: Li-
censure for Fewer Than All Conditions of Use
for Which the Reference Product Has Been Li-
censed Guidance for Industry, Draft Guidance
(PDF)
• Chemistry, Manufacturing, and Control (CMC)
Information for Human Gene Therapy Investi-
gational New Drug Applications (INDs) (PDF)
• Comparability Protocols for Human Drugs and
Biologics: Chemistry, Manufacturing, and Con-
trols Information Guidance for Industry, Draft
Guidance (PDF)
• Contract Manufacturing Arrangements for
Drugs: Quality Agreements (PDF)
Resources, Guidelines,
and Guidance Documents
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