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Titles
- S12 nonclinical biodistribution considerations for gene therapy products: guidance for industry1
- S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry1
- 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
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry1
- Smoking cessation and related indications: developing nicotine replacement therapy drug products : guidance for industry1
- Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Special protocol assessment1
- Special rules for the management of infants during the hot season: recommended by the Obstetrical Society of Philadelphia to the thoughtful attention of the mothers in Philadelphia : approved and published for distribution by the Board of Health1
- Statutes regulating the practice of physic and surgery in the State of New-York: and the by-laws of the Medical Society of the County of New-York, adopted July 14, 18281
- Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry1
- Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document1
- Submitting documents using real-world data and real-world evidence to FDA for drug and biological products1
- Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document1
- Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff1
- Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs1