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Titles
- S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers1
- S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers1
- Safety and performance based pathway: guidance for industry and Food and Drug Administration1
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals1
- Smallpox (variola virus) infection: developing drugs for treatment or prevention1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Special protocol assessment1
- Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research1
- Sunscreen: FDA reviewed applications for additional active ingredients and determined more data needed : report to Congressional committees1
- Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs1