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Titles
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- 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