52 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m
Resources: Guidelines
T
he regulatory nature of the bio/pharma-
ceutical industry requires close adher-
ence to regulations, good manufactuing
practices, and guidelines. The websites
of regulatory authorities provide information to as-
sist 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
International 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
COVID-19 Related Guidance Documents
• COVID-19 Container Closure System and
Component Changes: Glass Vials and
Stoppers, Guidance for Industry (PDF)
• COVID-19 Public Health Emergency:
General Considerations for Pre-IND Meeting
Requests for COVID-19 Related Drugs and
Biological Products (PDF)
• COVID-19: Developing Drugs and Biological
Products for Treatment or Prevention (PDF)
• Development and Licensure of Vaccines to
Prevent COVID-19 (PDF)
• Development of Monoclonal Antibody
Products Targeting SARS-CoV-2, Including
Addressing the Impact of Emerging Variants,
During the COVID 19 Public Health
Emergency (PDF)
• Emergency Use Authorization for Vaccines to
Prevent COVID-19 (PDF)
• Good Manufacturing Practice
Considerations for Responding to COVID-19
Infection in Employees in Drug and
Resources, Guidelines,
and Guidance Documents
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Access key regulatory and standard setting resources, guidance
documents, and guidelines by clicking on the title of the document.
