Resources, Guidelines, and Guidance Documents Directory
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Read this article in Pharmaceutical Technology's Regulatory Sourcebook March 2021 eBook.
Articles in this issue
It Takes a Bio/Pharma Village
Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling
Managing the Risk of Nitrosamine Impurities
Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development
Collaborative Efforts Address Key Data Integrity Challenges
Can FDA Reinvent Inspections
FDA 2021 Guidance Agenda Sees Focus on Generics
A Real-World Approach to Evaluating Cleanroom Garments
Resources, Guidelines, and Guidance Documents Directory
Regulatory and Standard Setting Organizations Directory
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
