Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 25, 2009
April 23, 2020
2d91b105-6b2c-4231-bcff-63a0d7fdc832
Related Documents
Individual Product Bioequivalence Recommendations for Specific Products
Guidance DocumentJune 10, 2010Center for Drug Evaluation and Research
End-of-Phase 2A Meetings
Guidance DocumentSeptember 18, 2009Center for Drug Evaluation and Research
Labeling OTC Human Drug Products; Small Entity Compliance Guide: Guidance for Industry
Guidance DocumentMay 13, 2009Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.