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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
- Safety testing of drug metabolites1
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff1
- Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals1
- Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies1
- 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
- State of Interoperability among U.S. non-federal acute care hospitals in 20181
- States follow a common framework in responding to breaches of Medicaid data1
- Statistical considerations for clinical trials during the COVID-19 public health emergency1
- Submission of plans for cigarette packages and cigarette advertisements (revised)1
- Summary of HHS's final rule on nondiscrimination in health programs and activities1
- Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff1
- Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs1