Titles
- Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry1
- Infant formula enforcement discretion policy: guidance for industry1
- Informed consent. Guidance for IRBs, clinical investigators, and sponsors1
- Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators1
- Instructions for use: patient labeling for human prescription drug and biological products : content and format1
- Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide1
- M10: bioanalytical method validation and study sample analysis : guidance for industry1
- M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry1
- Multiple endpoints in clinical trials: guidance for industry1
- Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff1
- Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry1
- 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
- Oncology drug products used with certain in vitro diagnostic tests: pilot program : guidance for industry, clinical laboratories, and Food and Drug Administration staff1
- Orange Book: questions and answers1
- Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer: guidance for industry1
- Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry1
- Policy regarding N-acetyl-L-cysteine: guidance for industry1