Guidances directory

All guidance documents2,320 total

• Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
• FDA Institutional Review Board Inspections: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
• CPG Sec 525325 Cumin Seed - Adulteration with Sand and GritCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550150 Apricots - Canned - Adulteration with InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525250 Cloves - Adulteration with StemsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 545600 Cinnamon-Flavored ToothpicksCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 545500 Silver-Plated Hollowware - Lead ContaminationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 545450 Pottery (Ceramics); Import and Domestic - Lead ContaminationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 570450 Tree Nuts - Adulteration with Filth, Involving the Presence of the Organism Escherichia coliCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 537100 Eggs and Egg Products - Frozen - Adulteration Involving DecompositionCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525900 Whole Plant (Unprocessed) Marjoram, Unground (Processed) Marjoram & Ground Marjoram - Adulteration by Insect & Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585775 Spinach, Canned or Frozen - Adulteration Involving Insects, DecompositionCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525150 Bay (Laurel) Leaves - Adulteration by Insect Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550350 Figs; Fig Paste - Adulteration Involving Insect Infestation; Mold, DirtCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550225 Cherries Brined, Fresh, Canned and Frozen - Adulteration Involving Rot and InsectCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550655 Peaches, Canned - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 590400 Natural Bristle Brushes (ie, Hair Brushes, Shaving Brushes) - Nit ContaminationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525700 Sesame Seeds - Adulteration with Insect Filth; Decomposition; Mammalian Excreta; Foreign MatterCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550800 Standardized Canned Fruit - Misbranding Involving Improper Declaration of Packing MediumCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 590300 Direct Reference Authority for Pseudomonas Contamination of Cosmetics Used in the Eye AreaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525625 Whole and Ground Pepper - Adulteration with Insect & Rodent Filth; Mold; Mammalian Excreta; Foreign MatterCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525300 Condimental Seeds Other than Fennel Seeds and Sesame Seeds - Adulteration by Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550690 Plums, Canned - Adulteration with RotCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525550 Mace - Adulteration with Insect Filth; Mold; Foreign Matter; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525500 Leafy Spices, Other than Bay Leaves - Whole Oregano Leaves, Whole Marjoram, Whole Sage Leaves and Whole Thyme Leaves - Adulteration with Insect Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550685 Pineapple, Canned; Imported and Domestic - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525200 Capsicum Pods, Ground Capsicums Excluding Paprika, Ground Paprika - Adulteration with Insect and Rodent Filth, Mold, Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 527225 Cheese - Misbranding Due to Moisture and FatCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 587300 Color AdditivesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525600 Whole and Ground Nutmeg - Adulteration with Insect Filth; Mold; Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 570425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 570300 Peanut Butter - Adulteration with Filth; GritCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 540590 Fish - Fresh and Frozen, as Listed - Adulteration by ParasitesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555880 Guidance Levels for Radionuclides in Domestic and Imported FoodsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550850 Strawberries; Frozen, Whole, or Sliced - Adulteration with Sand, MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525950 Whole Plant (Unprocessed) Sage, and Ground Sage - Adulteration by Insect and Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525925 Whole Plant (Unprocessed) Thyme, Unground (Processed) Thyme & Ground Thyme - Adulteration by Insect & Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550750 Raisins - Adulteration Involving Mold, Sand, Grit, & InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525850 Whole Plant (Unprocessed) Oregano, Crushed Oregano & Ground Oregano - Adulteration by Insect & Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food AllergensCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550700 Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - Adulteration Involving Insects; Decomposition; Dirt; Pits; and Pit FragmentsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525350 Fennel Seed - Adulteration by Mammalian Excreta; InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585825 Sweet Potatoes - Dyeing of Yellow and Red VarietiesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525330 Curry Powder - Adulteration by Insect and Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550600 Olives - Adulteration Involving Pits; Rot; Insect InfestationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585575 Peas and Beans; Dried - Adulteration Involving Storage, Insect Damage, RocksCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550500 Lingon Berries, Canned - Adulteration by InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585475 Canned Green Beans and Canned Wax Beans - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585400 Cowpeas (Black-Eyed Peas); Canned (Succulent Peas) - Adulteration by InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 515750 Cocoa Beans - Adulteration by Mold, Insect Infestation, and Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550300 Dates and Date Material; Imported and Domestic - Adulteration Involving Mold, Insect Excreta, Sour, Dirty, Worthless and PitsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585300 Corn, Sweet; Canned - Adulteration by Corn Ear Worms, Corn BorersCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585275 Brussels Sprouts, Frozen - Adulteration by InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550230 Cherries, Canned - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 545300 Foods, Rail Car Sanitation - AdulterationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550200 Drupelet Berries (Blackberries, Raspberries, Etc) - Common or Usual Names of Varieties; Canned and Frozen - Adulteration with Rot and InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 510500 Green Coffee Beans - Adulteration with Insects; MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550155 Apricot, Peach and Pear Nectars and Purees - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550100 Apple Butter - Adulteration with Mold; Rodent Filth, InsectCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 545400 Pottery (Ceramics); Import and Domestic - Cadmium ContaminationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 560200 Country of Origin LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 535100 Oleomargarine - Misbranding Due to Insufficient FatCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585200 Beets, Canned - Adulteration with RotCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 580100 Food Storage and Warehousing-Adulteration-Filth (Domestic and Import)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 570350 Peanuts, Shelled and Unshelled - Adulteration with Filth and Reject NutsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 527100 Butter - Adulteration Involving Insufficient Fat ContentCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525375 Whole Ginger - Adulteration with Insect Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585890 Tomato Products - Adulteration with Drosophila Fly Eggs and MaggotsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585875 Tomatoes - Canned - Misbranding Involving Food Standards (Peel)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585900 Tomato Products - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CVM GFI #135 Validation of Analytical Procedures for Type C Medicated FeedsGuidance Document · Center for Veterinary Medicine
• Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 104030)Guidance Document · Center for Devices and Radiological Health
• S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic DrugsGuidance Document · Center for Drug Evaluation and Research
• Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• How to Comply with the Pediatric Research Equity ActGuidance Document · Center for Drug Evaluation and Research
• M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug DictionariesGuidance Document · Center for Drug Evaluation and Research
• Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy VolunteersCenter for Drug Evaluation and Research
• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessGuidance Document · Center for Drug Evaluation and Research
• Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Nonclinical Studies for the Safety Evaluation of Pharmaceutical ExcipientsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 315100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 560400 Imported Milk and Cream - Federal Import Milk ActCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555425 Foods, Adulteration Involving hard or Sharp Foreign ObjectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 525225 - Whole Cassia or Whole Cinnamon, Ground Cinnamon - Adulteration by Insect and Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Evaluating the Risks of Drug Exposure in Human PregnanciesGuidance Document · Center for Drug Evaluation and Research
• Providing Regulatory Submissions in Electronic Format — Content of LabelingGuidance Document · Center for Drug Evaluation and Research
• E2E Pharmacovigilance PlanningGuidance Document · Center for Drug Evaluation and Research
• Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA ProductsGuidance Document · Center for Drug Evaluation and Research
• Premarketing Risk Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Development and Use of Risk Minimization Action Plans: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 300500 *Reprocessing of Single Use* DevicesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• E2B(M) Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
• Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601Guidance Document · Center for Drug Evaluation and Research
• Pharmacogenomic Data Submissions: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 310210 Blood Pressure Measurement Devices (Sphygmomanometers) - AccuracyCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFAGuidance Document · Center for Veterinary Medicine