Guidances directory

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All guidance documents2,854 total

Using Electronic Means to Distribute Certain Product Information: Guidance for IndustryGuidance Document · Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Policy
Draft Guidance for Industry and FDA Staff: Whole Grain Label StatementsGuidance Document · Human Foods Program
Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997Guidance Document · Center for Drug Evaluation and Research
Nonclinical Safety Evaluation of Pediatric Drug ProductsGuidance Document · Center for Drug Evaluation and Research
Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for IndustryGuidance Document · Office of the Commissioner
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Exploratory IND Studies: Guidance for Industry, Investigators, and ReviewersGuidance Document · Center for Drug Evaluation and Research
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMPGuidance Document · Center for Drug Evaluation and Research
CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP’s) - Phase IIGuidance Document · Center for Veterinary Medicine
Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in AnimalsGuidance Document · Center for Veterinary Medicine
Recommended Approaches to Integration of Genetic Toxicology Study ResultsGuidance Document · Center for Drug Evaluation and Research
Redbook 2000: IV.C.6. Carcinogenicity Studies with RodentsGuidance Document · Human Foods Program
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
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 515.775 Cocoa Powder, Press Cake - Adulteration with Insect and Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (Revised)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 570.700 Mixed Nuts - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 565.100 FDA Jurisdiction Over Meat and Poultry ProductsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 540.500 Tuna, Sable, Salmon, Shad-Smoked Cured, Adulteration Involving Food Additives, Sodium NitriteCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 562.550 Safety and Labeling of Waxed (Coated) Fruits and VegetablesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 540.420 Raw Breaded Shrimp - Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice RegulationsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 562.300 Foods - Net WeightCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 562.200 Foods - FPLA ComplianceCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 560.600 Clams, Mussels, Oysters; Fresh or Frozen - Adulteration by Bacteriological ContaminationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 590.500 Packaging Technologies and Tamper-Resistant Packaging Requirements for Cosmetic ProductsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 587.100 Label Declaration of Certification-Exempt Color AdditivesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 510.600 Dimethylnitrosamine in Malt BeveragesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 510.400 Dealcoholized Wine and Malt Beverages - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with PatulinCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 505.100 Bakery Products, Candy - "Catch-All" or "Shotgun" Ingredients DeclarationCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 500.450 Volatile N-Nitrosamines in Rubber Baby Bottle NipplesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 500.425 Use of Color Additives in Paper and Paperboard Intended for Use with FoodCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 500.200 Food Additives -"GRAS"Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002Guidance Document · Human Foods Program Office of Inspections and Investigations
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