Guidances directory

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All guidance documents2,854 total

S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution StudiesGuidance Document · Center for Drug Evaluation and Research
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesGuidance Document · Center for Drug Evaluation and Research
CPG Sec 525825 Vinegar, Definitions - Adulteration with Vinegar EelsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 550680 Pineapple, Canned; Pineapple Juice - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening ConditionsGuidance Document · Center for Drug Evaluation and Research
CPG Sec 398350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports of AssemblyGuidance Document · Office of Regulatory Affairs
E2A Clinical Safety Data Management: Definitions and Standards for Expedited ReportingGuidance Document · Center for Drug Evaluation and Research
CPG Sec 550260 Cranberry Sauce - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 525425 Hops - Adulteration Involving Aphid InfestationCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 300400 Contamination of Devices Labeled as SterileCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 448100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec 555300 Foods, Except Dairy Products - Adulteration with SalmonellaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 345100 Condoms; Defects - Criteria for Direct Reference SeizureCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 550590 Cloudberries (Multer Berries), Canned - Adulteration by InsectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 355200 Electrical Muscle StimulatorsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec 515100 Confectionery - Use of Non-Nutritive Substances as IngredientsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 550250 Citrus Fruit Juices, Canned - Adulteration with Fly Filth and MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 550235 Cherry Jam - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 585225 Black-Eyed Peas (Cow Peas, Field Peas); Dried-Adulteration with Lygus Bug DamageCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 250500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices is obsolete and was withdrawn on 7/16/2018Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 480.200 Expiration Dating of Unit Dose Repackaged DrugsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec 578.600 Unapproved Additives for Exported GrainsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds (Withdrawn 7/23/2019)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 650.100 Animal Drugs for Euthanasia (Withdrawn 5/23/2024)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 690.100 Nutritional Supplements for Companion Animals (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 689.100 Direct-Fed Microbial ProductsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 687.500 Silage IngredientsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 685.100 Recycled Animal WasteCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 480.100 Requirements for Expiration Dating and Stability TestingCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
CPG Sec. 680.600 Sequencing as a Means to Prevent Unsafe Drug Contamination in the Production, Storage, and Distribution of Feeds (Withdrawn 1/30/2023)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 680.500 Unsafe Contamination of Animal Feed from Drug Carryover (Withdrawn 1/30/2023)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 675.300 Moisture Damaged GrainCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 675.200 Diversion of Adulterated Food to Acceptable Animal Feed UseCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 675.100 Diversion of Contaminated Food for Animal UseCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 670.500 Ammoniated Cottonseed Meal - Interpretation of 21 CFRCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 665.100 Common or Usual Names for Animal Feed Ingredients (Withdrawn 1/6/2025)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec 562.400 Foreign Language Declarations on Food LabelsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec. 654.200 Teat Dips and Udder Washes for Dairy Cows and GoatsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 643.100 Oral Iron Products for Baby Pigs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 642.100 *Drugs for Odor Control and Conception in Pet Animals*Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 640.100 Anthelmintics (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
CPG Sec. 150.500 Analytical Methodology Used by FDA - DrugsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations Center for Drug Evaluation and Research
CPG Sec. 638.100 Process Validation Requirements for Drug Products Subject to Pre-Market ApprovalCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 637.100 Plastic Containers for Injectable Animal Drugs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product LabelsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec.625.400 Reconditioning of New Animal Drugs Seized Under Section 501(a)(5) (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec 555.650 Reconditioning Foods by Diversion for Animal FeedCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e)Guidance Document · Office of Regulatory Affairs
CPG Sec. 607.100 - Adequate Directions for Use (Species Designation) - Animal Drugs and Veterinary DevicesCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 398.375 Obligations of Factory-based Manufacturers and Assemblers of Diagnostic X-ray Equipment Under the Performance Standard for Diagnostic X-ray EquipmentGuidance Document · Office of Regulatory Affairs
CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device ManufacturersCompliance Policy Guide (CPG) · Office of Regulatory Affairs Center for Devices and Radiological Health
CPG Sec. 398.200 Hazardous Diagnostic X-ray SystemsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 396.400 Policy on Warned on Sunlamp ProductsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 396.200 Exemption for Certain Sunlamp Product Purchaser RecordsGuidance Document · Office of Regulatory Affairs
CPG Sec 525.400 Hollandaise Sauce - Common or Usual NameCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning ProductsGuidance Document · Office of Regulatory Affairs
CPG Sec. 394.100 Retention of Microwave Oven Test RecordsGuidance Document · Office of Regulatory Affairs
CPG Sec 520.100 Canned Foods, Use of the Term "Solid Pack"Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 550.400 GrenadineCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 515.425 Sugar - Water Damaged - ReconditioningCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 310.100 Pacemaker ReuseCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling RequirementsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
CPG Sec 275.100 Immune Milk (Withdrawn 1/30/2020) : CPG Sec 275.100 Immune MilkCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 253.100- Use of Units of *Plasma and Fresh Frozen Plasma* Which Have Been ThawedGuidance Document · Office of Regulatory Affairs
CPG Sec. 252.100 Source Plasma - Regulatory Action Based on Overbleeding (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 250.100 Source Plasma – Guidelines for Informed Consent Forms (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
CPG Sec. 231.110- Quality Control Testing of *Platelets* [ ] and Cryoprecipitated Antihemophilic Factor [ ]Compliance Policy Guide (CPG) · Office of Regulatory Affairs
Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip SystemsGuidance Document · Center for Devices and Radiological Health
CVM GFI #57 Preparation and Submission of Veterinary Master FilesGuidance Document · Center for Veterinary Medicine
Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and UrologyGuidance Document · Center for Devices and Radiological Health
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsGuidance Document · Center for Devices and Radiological Health
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersGuidance Document · Center for Devices and Radiological Health
Format and Content for the CMC Section of an Annual ReportGuidance Document · Center for Drug Evaluation and Research
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)Guidance Document · Center for Devices and Radiological Health
CPG Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
E7 Studies in Support of Special Populations: GeriatricsGuidance Document · Center for Drug Evaluation and Research
Points to Consider for Cervical Cytology DevicesGuidance Document · Center for Devices and Radiological Health
Guidance for the Content of Premarket Notifications for Urine Drainage BagsGuidance Document · Center for Devices and Radiological Health
CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol DevelopmentGuidance Document · Center for Veterinary Medicine
CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic AnimalsGuidance Document · Center for Veterinary Medicine
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone CementGuidance Document · Center for Devices and Radiological Health
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom ProductsGuidance Document · Center for Devices and Radiological Health
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 102031(g) :Guidance Document · Center for Devices and Radiological Health
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps ContainersGuidance Document · Center for Devices and Radiological Health
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and ActuatorsGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Guidelines for Determining Metric Equivalents of Household MeasuresGuidance Document · Human Foods Program
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)Memorandum · Center for Biologics Evaluation and Research
1993 Draft Redbook IIGuidance Document · Human Foods Program
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesGuidance Document · Center for Devices and Radiological Health
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical DrapesGuidance Document · Center for Devices and Radiological Health
CVM GFI #45 Guideline for Uniform Labeling of Drugs for Dairy and Beef CattleGuidance Document · Center for Veterinary Medicine
Study and Evaluation of Sex Differences in the Clinical Evaluation of Drugs: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood ProductsMemorandum · Center for Biologics Evaluation and Research