"Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices | FDA
practice, medicine, off, label, use, unapproved, significant, change, risk, marketed, intent
Research
BIORESEARCH + "methnames"Bioethics web archive : Free Web : Free Download, Borrow and Streaming : Internet Archive
Search General and Cross-Cutting Topics Guidance Documents | FDA
Collection of FDA guidance documents on cross-cutting topics
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use | FDA
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
How to Prepare a Pre-Request for Designation (Pre-RFD) | FDA
Guidance for Industry: How to Prepare a Pre-Request for Designation (Pre-RFD)
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | FDA
Draft Guidance for Industry and FDA Staff, Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products | FDA
Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA | FDA
Draft guidance for industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA
How to Write a Request for Designation (RFD) | FDA
Guidance for Industry - How to Write a Request for Designation (RFD)
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | FDA
Guidance for Industry and FDA Staff - Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Early Development Considerations for Innovative Combination Products | FDA
Guidance for Industry and FDA Staff -Early Development Considerations for Innovative Combination Products
Application User Fees for Combination Products | FDA
Guidance for Industry and FDA Staff - Application User Fees for Combination Products
About Combination Products | FDA
Combination product definition, reports, examples and common questions.
Combination Product Definition Combination Product Types | FDA
Regulatory definitions of a combination products regulated by the Food and Drug Administration
Combination Products Policy Council | FDA
About the FDA's Combination Products Council
FDA Voices: Perspectives From FDA Experts
Policy / Consumer Safety and Enforcement / Medical Products / Food / Tobacco
FDA Voices: Perspectives From FDA Leadership and Experts | FDA
FDA Voices provides expert perspectives and insights into the agency's work on a variety of topics, issues and policies, in the areas of medical products, food, tobacco, policy, and consumer safety and enforcement.
FDA Voices: Perspectives From FDA Leadership and Experts | FDA
FDA Voices provides expert perspectives and insights into the agency's work on a variety of topics, issues and policies, in the areas of medical products, food, tobacco, policy, and consumer safety and enforcement.
International Council for Harmonisation (ICH) Guidance Documents | FDA
International Council for Harmonisation (ICH) Guidance Documents | FDA
Cross-cutting Guidance Documents | FDA
Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes.
Cross-cutting Guidance Documents | FDA
Guidance documents issued by the FDA Office of the Commissioner and covering topics affecting multiple regulated products and administrative processes.