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Guidance Documents/Guidance

Guidance Documents

Browse 2,246 guidance documents from FDA and regulatory agencies.

Guidance Documents

2,246 documents available

5 shown

Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry

Guidance Document
November 10, 2026
🏢Office of the Commissioner
biologics
Original Document
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Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff

Guidance Document
November 10, 2026
🏢Center for Devices and Radiological Health
devices
Original Document
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Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus: Guidance for Industry

Guidance Document
November 3, 2026
🏢Center for Biologics Evaluation and Research
biologics
Original Document
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Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products

Guidance Document
November 2, 2026
🏢Center for Biologics Evaluation and Research
biologics
Original Document
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E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for Industry

Guidance Document
October 30, 2026
🏢Center for Drug Evaluation and Research
drugs
Original Document
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Total Documents2,246
Document TypeGuidance
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