Guidances directory

All guidance documents2,828 total

• Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo UseGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 527200 Cheese & Cheese Products - Adulteration with FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 585675 Popcorn - Adulteration with Rodent Filth and Field CornCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 505500 Macaroni and Noodle Products - Adulteration Involving Insect Fragments and Rodent HairsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 160.500 Answering Inquiries on Status of Criminal ReferralsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 527.600 Use of DDVP (dichlorvos) Strips in Milkhouses and MilkroomsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 527.500 Malted MilkCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - ReconditioningCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)Memorandum · Center for Biologics Evaluation and Research
• Variance from Manufacturer Report Number Format [MDR letter]Guidance Document · Center for Devices and Radiological Health
• E3 Structure and Content of Clinical Study ReportsGuidance Document · Center for Drug Evaluation and Research
• Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsGuidance Document · Center for Drug Evaluation and Research
• E4 Dose-Response Information to Support Drug RegistrationGuidance Document · Center for Drug Evaluation and Research
• Effective Visual Control of Laser Projections (Laser Notice 47)Guidance Document · Center for Devices and Radiological Health
• Suggested Format For IDE Progress ReportGuidance Document · Center for Devices and Radiological Health
• Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV): Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• S2A Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Medical Device Reporting for User FacilitiesGuidance Document · Center for Devices and Radiological Health
• Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived ProductsGuidance Document · Center for Drug Evaluation and Research Center for Biologics Evaluation and Research
• Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)Guidance Document · Center for Devices and Radiological Health
• Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)Guidance Document · Center for Devices and Radiological Health
• Q1B Photostability Testing of New Drug Substances and ProductsGuidance Document · Center for Drug Evaluation and Research
• S1A The Need for Long-term Rodent Carcinogenicity Studies of PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
• Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsGuidance Document · Center for Drug Evaluation and Research
• All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)Industry Letter · Center for Devices and Radiological Health
• Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated PlasmapheresisMemorandum · Center for Biologics Evaluation and Research
• Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationGuidance Document · Center for Drug Evaluation and Research
• Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care FacilitiesGuidance Document · Center for Devices and Radiological Health
• User Instruction for Medical Products (Laser Notice 44)Guidance Document · Center for Devices and Radiological Health
• Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen: Memorandum to All Registered Blood EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)Guidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesGuidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling DevicesGuidance Document · Center for Devices and Radiological Health
• Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise EquipmentGuidance Document · Center for Devices and Radiological Health
• FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsGuidance Document · Center for Biologics Evaluation and Research
• Testing Guidance for Male Condoms Made From New Material (Non-Latex)Guidance Document · Center for Devices and Radiological Health
• Guidance for Industry: Letter to Manufacturers, Importers, and Distributors of Imported Candy and Candy WrappersIndustry Letter · Human Foods Program
• CPG Sec 100.900 International Memoranda of UnderstandingCompliance Policy Guide (CPG) · Center for Veterinary Medicine Human Foods Program Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Tobacco Products
• Guidance on the Content and Organization of a Premarket Notification for a Medical LaserGuidance Document · Center for Devices and Radiological Health
• Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant ComponentsGuidance Document · Center for Devices and Radiological Health
• Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors: Memorandum to Licensed EstablishmentsMemorandum · Center for Biologics Evaluation and Research
• CPG Sec. 625.500 Failure to Register *and/or Drug List* (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for *Warning* Letter Issuance (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 370.100 Cytotoxic Testing for Allergic DiseasesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 345.300 Menstrual SpongesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 457.100 Pangamic Acid and Pangamic Acid Products Unsafe for Food and Drug UseGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 456.100 Non-Rx Drugs Anti-Obesity PreparationsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination ProductsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 450.200 Drugs - General Provisions and Administrative Procedures for Recognition as Safe and EffectiveGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and ClaimsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 120.500 Health Fraud - Factors in Considering Regulatory ActionCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 400.500 Identical or Similar Product NamesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 400.200 Consistent Application of CGMP DeterminationsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 587.200 Uncertified or Delisted Colors in Foods for Export - (e.g., FD&C Red #2)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 355.300 Ion Generating DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec 515.600 Candied Citron - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 515.400 Raw SugarCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 500.400 Use of Calcium Chloride as a Drying Agent in Such Products as Packaged Potato Chips and PeanutsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 231.130- Storage of *Platelets* [ ] for up to five (5) Days is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 231.120- Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing *Platelets* and Fresh Frozen Plasma* is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 231.100- *Platelets, Pooled* is obsolete and was withdrawn on 7/16/2018.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG 230.130- Adequate Space for Determination of Donor Suitability (Obsolete, Withdrawn on 7/16/2018)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 550270 Currants - Adulteration Involving Wormy FruitsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 550450 Jam, Black Currant - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 480300 Lack of Expiration Date of Stability DataCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 575100 Pesticide Residues in Food and Feed - Enforcement CriteriaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 400100 Drugs, Human - Failure to RegisterCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Q2A Text on Validation of Analytical ProceduresGuidance Document · Center for Drug Evaluation and Research
• 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