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Titles
- 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
- Multiple endpoints in clinical trials: guidance for industry1
- Orange Book: questions and answers1
- 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 regarding N-acetyl-L-cysteine: guidance for industry1
- Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff1
- Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff1
- Q3D(R2) elemental impurities1
- Recommendations to reduce the risk of transfusion-transmitted malaria: guidance for industry1
- Referencing the definition of “device” in the Federal Food, Drug, and Cosmetic Act in guidance, regulatory documents, communications, and other public documents: guidance for industry and Food and Drug Administration staff1
- Refusal of inspection by a foreign food establishment or foreign government: guidance for industry1
- Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps): small entity compliance guide : guidance for industry1
- Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff1
- S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry1
- Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry1
- Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial: guidance for industry1
- Submitting documents using real-world data and real-world evidence to FDA for drug and biological products1
- Tobacco products: principles for designing and conducting tobacco product perception and intention studies1