S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 1, 1996
June 8, 2021
47727f71-5bb8-4ab4-b93a-c974612755da
Related Documents
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Guidance DocumentFebruary 23, 1996Center for Drug Evaluation and Research
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
Guidance DocumentMarch 1, 1995Center for Drug Evaluation and Research
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Guidance DocumentJuly 1, 1996Center 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.