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Titles
- Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry1
- Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators1
- Nontuberculous mycobacterial pulmonary disease caused by mycobacterium avium complex: developing drugs for treatment : guidance for industry1
- Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff1
- Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry1
- Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry1
- Rare diseases: considerations for the development of drugs and biological products : guidance for industry1
- Real-time oncology review (RTOR): guidance for industry1
- Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry1
- Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry1
- Registration and listing of cosmetic product facilities and products: guidance for industry1
- Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document1
- Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document1
- Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff1
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff1
- Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry1
- Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry1