From OpenCongress Wiki

Contents 1 Overview 1.1 Basics 1.2 FDA Initiatives 2 Information for Consumers 2.1 Product Recalls  2.2 Product Approvals  2.3 Additional Consumer Information  2.3.1 Food 2.3.2 Drugs 2.3.3 Medical Devices 2.3.4 Biologics 2.3.5 Veterinary 2.3.6 Cosmetics 2.3.7 Radiation-Emitting Products 2.3.8 Tobacco 3 Information for Industry 3.1 General Resources 3.2 Industry-Specific Information 3.2.1 Food 3.2.2 Drug 3.2.3 Medical Devices 3.2.4 Biologics 3.2.5 Veterinary 3.2.6 Cosmetics 3.2.7 Radiation-Emitting Products 3.2.8 Tobacco 4 Enforcement  4.1 Inspections Information 4.2 Correspondance with Industry  4.3 Compliance Pages 4.4 Laws and Regulations 4.5 Enforcement Resources for Consumers  5 Transparency  5.1 Transparency Task Force Activity 5.2 Transparency Resources

Overview

The Food and Drug Administration is a federal agency that regulates Food, Drugs, Biologics, Cosmetics, Medical Devices, Radiation-Emitting Electronic Products, Veterinary Products and Tobacco. 

The FDA website has a variety of resources and information for both consumers and for the industries it regulates. The FDA also has an ongoing transparency initiative that aims to make more regulatory information available to the public. 

The FDA has made some of its datasets available on its "Open Government" Page: http://www.fda.gov/AboutFDA/Transparency/OpenGovernment/default.htm

Basics

About the FDA: http://www.fda.gov/AboutFDA/default.htm

Commissioners Page: http://www.fda.gov/AboutFDA/CommissionersPage/default.htm

Advisory Committees: http://www.fda.gov/AdvisoryCommittees/default.htm

Consumers and Patients Portal: http://www.fda.gov/ForConsumers/default.htm?utm_source=fda&utm_medium=website&utm_term=ForConsumers&utm_content=Con&utm_campaign=Consumer

Health Professionals Portal: http://www.fda.gov/ForHealthProfessionals/default.htm?utm_source=fda&utm_medium=website&utm_term=ForHealthProfessionals&utm_content=Hpro&utm_campaign=HealthProf

Scientists and Researchers Portal: http://www.fda.gov/ScienceResearch/default.htm?utm_source=fda&utm_medium=website&utm_term=ScienceResearch&utm_content=Sci&utm_campaign=Scientist

Industry Portal: http://www.fda.gov/ForIndustry/default.htm?utm_source=fda&utm_medium=website&utm_term=ForIndustry&utm_content=Ind&utm_campaign=Industry

FDA Initiatives

Public Health Focus: http://www.fda.gov/NewsEvents/PublicHealthFocus/default.htm?utm_source=fda&utm_medium=website&utm_term=PublicHealthFocus&utm_content=phf&utm_campaign=PHF

Focus on Innovation: http://www.fda.gov/AboutFDA/Innovation/default.htm

Globalization: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm

Advancing Regulatory Science: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm

Medical Countermeasures Initiative: http://www.fda.gov/EmergencyPreparedness/MedicalCountermeasures/default.htm

Sentinel Initiative: http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm

Emergency Preparedness and Response: http://www.fda.gov/EmergencyPreparedness/default.htm

Consumer Email Alert Service: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm#recall

FDA Basics Webinars: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm197102.htm

Information for Consumers

Product Recalls 

FDA Main Recall Page: http://www.fda.gov/Safety/Recalls/default.htm 

Medical Device Recall Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Drug Recall Press Releases: http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm

Biologics Recalls by Year: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm

Animal and Veterinary Recall Press Releases: http://www.fda.gov/AnimalVeterinary/SafetyHealth/RecallsWithdrawals/default.htm 

Product Approvals 

Product Approvals Page: http://www.fda.gov/NewsEvents/ProductsApprovals/default.htm

New and Generic Drug Approvals: http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm

Drug and Biologic Approvals Reports: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/default.htm

Drug Approval Search Function: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

Medical Device Approvals by Year: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/default.htm

Additional Consumer Information 

Food

Food Facts: http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm077286.htm

CFSAN Constituent Updates: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm

Foodborne Illness: http://www.fda.gov/Food/FoodSafety/FoodborneIllness/default.htm

Biotechnology Policy: http://www.fda.gov/Food/Biotechnology/default.htm

Dietary Supplements: http://www.fda.gov/Food/DietarySupplements/default.htm

Food Defense and Emergency Response: http://www.fda.gov/Food/FoodDefense/default.htm

Food ingredients and Packaging: http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm

Food Safety Page: http://www.fda.gov/Food/FoodSafety/default.htm 

Food Labeling and Nutrition: http://www.fda.gov/Food/LabelingNutrition/default.htm

Science and Research: http://www.fda.gov/Food/ScienceResearch/default.htm

Drugs

MedWatch program: http://www.fda.gov/Safety/MedWatch/default.htm

Drug Safety Newsletter: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/default.htm

Drug Shortages: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

Drug Database: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

"Orange Book": http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

National Drug Code Directory: http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

Drug Emergency Preparedness: http://www.fda.gov/Drugs/EmergencyPreparedness/default.htm

Drug Safety and Availability Resources: http://www.fda.gov/Drugs/DrugSafety/default.htm

Drug Development and Approval Process: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

Understanding Generic Drugs: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default.htm

Medicine Guides: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm

Medication Health Fraud: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/default.htm

Medical Devices

Medical Device Database: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm

Safety Notices: http://www.fda.gov/MedicalDevices/Safety/default.htm

Science and Research Information: http://www.fda.gov/MedicalDevices/ScienceandResearch/default.htm

Medical Device Reporting for Consumers: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

Products and Medical Procedures: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/default.htm

Consumers Key Topics: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm

Choosing a Medical Device: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ChoosingaMedicalDevice/default.htm 

Biologics

Biologic Product Shortages: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/default.htm

Allergenics Resources: http://www.fda.gov/BiologicsBloodVaccines/Allergenics/default.htm

Blood and Blood Products Resources: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm

Cellular and Gene Therapy Resources: http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm

TIssue and Tissue Products Resource Page: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/default.htm

Vaccines Information: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/default.htm

Xenotransplantation Information: http://www.fda.gov/BiologicsBloodVaccines/Xenotransplantation/default.htm

Biologics Development and Approval Process: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/default.htm

Safety and Availability Information by Year: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/default.htm

Science and Research Information: http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/default.htm

Veterinary

Animal Drug Database: http://www.accessdata.fda.gov/scripts/animaldrugsatfda/

Pet Food Label Information: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047113.htm

Consumer Updates: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047313.htm

Consumer Topic Fliers: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/default.htm

Safety and Health Information: http://www.fda.gov/AnimalVeterinary/SafetyHealth/default.htm

Science and Research Information: http://www.fda.gov/AnimalVeterinary/ScienceResearch/default.htm

Cosmetics

Cosmetic Labeling: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm

Color Addatives and Cosmetics: http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.htm

Cosmetic Exports: http://www.fda.gov/Cosmetics/InternationalActivities/ImportsExports/CosmeticExports/default.htm

Cosmetic Imports: http://www.fda.gov/Cosmetics/InternationalActivities/ImportsExports/CosmeticImports/default.htm

Press Releases: http://www.fda.gov/Cosmetics/NewsEvents/ucm203298.htm

Product and Ingredient Safety: http://www.fda.gov/Cosmetics/ProductandIngredientSafety/default.htm

Hypoallergenic Cosmetics: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/LabelClaimsandExpirationDating/ucm2005203.htm

Radiation-Emitting Products

Products and Procedures Information: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/default.htm

List of Regulated Products: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/ucm135878.htm

Radiation Safety: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/default.htm

Mammography Quality Standards Act and Program Information: http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm

Radiation-Emitting Products News: http://www.fda.gov/Radiation-EmittingProducts/NewsEventsRadiationEmittingProducts/default.htm

Tobacco

News and Press Releases: http://www.fda.gov/TobaccoProducts/NewsEvents/default.htm

Tobacco Labeling: http://www.fda.gov/TobaccoProducts/Labeling/default.htm

Protecting Kids from Tobacco: http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/default.htm

Resources to Quit Smoking: http://www.fda.gov/TobaccoProducts/ResourcesforYou/default.htm

Cigarette Health Warnings: http://www.fda.gov/TobaccoProducts/Labeling/CigaretteWarningLabels/default.htm

Electronic Cigarettes: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

Compliance Check Inspections of Tobacco Product Retailers and Civil Money Penalty Complaints: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm232109.htm

Tobacco Products Scientific Advisory Committee: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/default.htm

Information for Industry

General Resources

Industry Guidance Documents: http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

Recall Guidance Information: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

FDA Standards: http://www.fda.gov/RegulatoryInformation/Standards/default.htm

FDA Forms: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm

Industry-Specific Information

Food

Good Manufacturing Practices: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/default.htm

Reportable Food Registry: http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm

Retail Food Protection: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/default.htm

Registration of Food Facilities: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/default.htm

Industry Guidance Documents: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm

Drug

Prescription Drug User Fee Act: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

Drug Guidance Documents: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Medical Devices

Medical Device Guidance Documents: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

Device Advice: Regulatory Assistance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

Device Registration: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm

Importing and Exporting Devices: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/default.htm

Device Classification: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

Bioresearch Monitoring: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/BioresearchMonitoring/default.htm

Medical Device Recognized Consensus Standards http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Standards and Guidance Resource Page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm

Biologics

General Biologics Guidances: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/General/default.htm 

Biologics Forms: http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/BiologicForms/default.htm

Importing and Exporting: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/default.htm

Biologics Procedures: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/default.htm

Biologics Rules: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/default.htm

Memoranda to Blood Establishments: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/default.htm

Blood Establishment Registration: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm

Biologics License Applications Process: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/default.htm 

Veterinary

Veterinary Guidances: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm

Development and Approval Process: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/default.htm

Veterinary Compliance Manual: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm117042.htm

Veterinary Rules and Regulations: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/default.htm

New Animal Drug Application: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/NewAnimalDrugApplications/default.htm

User Fees and Related Information: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/UserFees/default.htm

Reportable Food Registry for Industry: http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm

Adverse Event Reporting for Manufacturers: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm

Veterinary Feed Directive: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm

Cosmetics

Cosmetics Guidance Documents: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm

Voluntary Cosmetic Registration Program: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm

Good Manufacturing Practices: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm

Cosmetics Laws and Regulations: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/default.htm

Resource Page for Cosmetic Manufacturers, Packagers and Distributors: http://www.fda.gov/Cosmetics/ResourcesForYou/CosmeticsManufacturersPackagersDistributors/default.htm

Radiation-Emitting Products

Getting a Radiation-Emitting Product to Market: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/default.htm

Laws and Regulations: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/LawsandRegulations/default.htm

Guidance Documents: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/IndustryGuidance/default.htm

Industry Assistance Walk-through: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/ucm202505.htm

Importing and Exporting Electronic Products: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/ImportingandExportingElectronicProducts/default.htm

Performance Standards: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/PerformanceStandards/default.htm

Product Codes for Radiation-Emitting Products: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/PerformanceStandards/ucm135508.htm

Records and Reporting: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RecordsandReporting/default.htm

Tobacco

Guidance Documents: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm

Industry Meeting Request Procedure: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm220445.htm

Small Business Assistance: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm189635.htm

Information from Importers: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm290823.htm

Information for Manufacturers: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ForManufacturers/default.htm

Information for Wholesalers and Distributors: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ForWholesalersDistributors/default.htm

Enforcement 

Inspections Information

Inspections Database: http://www.accessdata.fda.gov/scripts/inspsearch/

Inspections Reference Materials: http://www.fda.gov/ICECI/Inspections/default.htm

Inspections Guides: http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm

CDRH Inspections Database: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm223770.htm

Investigations Operations Manual, Inspections Chapter: http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf

Foreign Inspections: http://www.fda.gov/ICECI/Inspections/ForeignInspections/default.htm

Field Management Directives: http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/default.htm

Correspondance with Industry 

Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm 

Assorted Letters to Industry: http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm284105.htm

Medical Device Letters to Industry: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm

Warning Letters to Pharmaceutical Companies: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm

Veterinary Advisory Action Letters: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/ucm042132.htm

Cosmetics Warning Letters: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ComplianceEnforcement/WarningLetters/default.htm

Tobacco Retailer Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/default.htm

Compliance Pages

The FDA maintains a "Compliance Page" for each of the regulatory areas. These pages are a compliation of compliance activities, documents for consumers, and resources for industry.

Biologics Compliance Page: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/default.htm

Animal and Veterinary Compliance Page: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/default.htm

Food Compliance Page: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/default.htm

Drugs Compliance Page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm

Medical Devices Compliance Page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ComplianceActivities/default.htm

Cosmetics Compliance Page: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/default.htm

Tobacco Compliance Page: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm

Compliance Manuals: http://www.fda.gov/ICECI/ComplianceManuals/default.htm

Laws and Regulations

Regulatory Information Page: http://www.fda.gov/RegulatoryInformation/default.htm

FDA-related Legislation: http://www.fda.gov/RegulatoryInformation/Legislation/default.htm

Collection of Laws Affecting the FDA: http://www.fda.gov/RegulatoryInformation/Legislation/ucm153119.htm

The Federal Food, Drug, and Cosmetic Act: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

Federal Food and Drug Regulations: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Laws Enforced by the FDA: http://www.fda.gov/AboutFDA/WhatWeDo/Laws/default.htm

FDA Standards: http://www.fda.gov/RegulatoryInformation/Standards/default.htm

FDA Guidances: http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

Enforcement Resources for Consumers 

Debarment List: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm

Cargo Theft Notifications: http://www.fda.gov/ICECI/CriminalInvestigations/ucm182888.htm 

Counterfeit Medicine Press Releases: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

Criminal Investigations Press Releases: http://www.fda.gov/ICECI/CriminalInvestigations/ucm123086.htm

General Press Releases: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm

To Report a Problem: http://www.fda.gov/Safety/ReportaProblem/ucm055676.htm

To Report Criminal Activity: http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm

Weekly Enforcement Reports: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm

Annual Enforcement Statistics: http://www.fda.gov/ICECI/EnforcementActions/ucm247813.htm 

Transparency 

Transparency Task Force Activity

Transparency Initiative Reports: http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm

"FDA Basics" Page [to provide basic information and context for consumers]: http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm

Transparency Dialogue with Industry: http://www.fda.gov/AboutFDA/Transparency/TransparencytoRegulatedIndustry/default.htm

Phase II Transparency Report: Public Disclosure Policy: http://www.fda.gov/AboutFDA/Transparency/PublicDisclosure/default.htm

FDA Transparency Blog: http://fdatransparencyblog.fda.gov/

Transparency Resources

FOIA Electronic Reading Room:

http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/default.htm

Freedom Of Information Act Resources: http://www.fda.gov/RegulatoryInformation/FOI/default.htm

Public Comment and Petition for Proposed Regulations: http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

Congressional Testimony: http://www.fda.gov/NewsEvents/Testimony/default.htm

Public Meetings sponsored by the FDA: http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/default.htm

Speeches by FDA Officials: http://www.fda.gov/NewsEvents/Speeches/default.htm

Interactive Media and Blogs: http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm

Dockets Managment: http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

FDA-TRACK Program: http://www.fda.gov/AboutFDA/Transparency/track/default.htm