52 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m
Resources: Guidelines
T
he following are some of the notable
regulatory and standard setting resources,
guidance documents, and guidelines.
UNITED STATES
The following are some key websites addressing
regulatory requirements for biologics and other drug
products*.
FDA.gov
• Vaccines, Blood, and Biologics
• Guidance, Compliance, & Regulatory
Information
• FDA Guidance Documents
• FDA Regulatory Science
• FDA Compliance Actions and Activities
• FDA Warning Letters
Additional Resources
• Federal Register
• Federal Code of Regulations
FDA Guidance Documents
FDA's website provies a variety of regulatory resources
including its list of current guidance documents. The
following are some relevant guidance documents
published in 2018 and 2019.
Final Guidances
• Postmarketing Safety Reporting for
Combination Products: Guidance for Industry
and FDA Staff
• Population Pharmacokinetics
• Considerations in Demonstrating
Interchangeability with a Reference Product
• Oncology Pharmaceuticals: Reproductive
Toxicity Testing and Labeling
Recommendations
• REMS: FDA's Application of Statutory Factors in
Determining When a REMS Is Necessary
• Pediatric Information Incorporated into Human
Prescription Drug and Biological Products
Labeling Good Review Practice
• Providing Regulatory Submissions in Electronic
Format–Certain Human Pharmaceutical
Product Applications and Related Submissions
Using the eCTD Specifications
• Immunogenicity Testing of Therapeutic Protein
Products—Developing and Validating Assays
for Anti-Drug Antibody Detection
• Labeling for Human Prescription Drug and
Biological Products Approved Under the
Accelerated Approval Regulatory Pathway
• Data Integrity and Compliance With Current
Good Manufacturing Practice
Resources, Guidelines,
and Guidance Documents
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