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                FDA Basics for Industry

FDA Basics for Industry

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    PrintGeneral Navigation Guide for Manufacturers of FDA-Regulated Products and Start-upsLaws and RegulationsThe Food and Drugs Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. You can find online some of the laws and regulations governing FDA-regulated industries.Code of Federal Regulations (Title 21)Federal Food, Drug, and Cosmetic ActOther Laws Affecting FDASafety InformationFDA provides post market safety information for some FDA-approved drugs online as well as information about the Risk Evaluation Mitigation Strategies (REMS) approved by the agency.MedWatchRecalls, Market Withdrawals, and Safety AlertsIndex to Drug-Specific InformationMedication GuidesApproved Risk Evaluation and Mitigation Strategies (REMS)Enforcement ReportsApprovals and ClearancesFDA posts information about products that the agency has approved or cleared for marketing.Animal Drugs Approved Animal Drug ProductsDrugs Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)Drug and Biologic Approval ReportsDrug Approval Reports by MonthNew and Generic Drug ApprovalsNew Pediatric Information in Labeling (PDF - 1.15MB)Food Food and Color Additives: Final Rules By YearMedical Devices Recently Approved Devices510(k) ClearancesPMA ApprovalsRadiation-Emitting Products Radiation-Emitting Products Industry Assistance: Walk-throughVaccines, Blood, Biologics Product Approvals and Clearances (Including Supporting Documents, Product/Manufacturer Lists, and Related Resources)ManualsFDA posts manuals that set forth policies and procedures that govern some of the agency's activities.Regulatory Procedures ManualInvestigations Operations ManualManual of Policies and Procedures (CDER)Standard Operating Policies and Procedures (CBER)Staff Manual Guides Bacteriological Analytical ManualCompliance Program Guidance ManualManual of Compliance Policy GuidesORA Laboratory ManualPesticide Analytical Manual (PAM)FormsThis collection includes forms for applications and submissions, reports and accountability, certifications, and inspections. Forms are listed by topic area (e.g., Cosmetics, Foods, Human Drugs, Safety & Problem Reports, Field Operations, etc.) or can be sorted alphabetically or numerically. The most frequently accessed forms by drug sponsors are included in a separate link.FDA FormsForms & Reports

                                                                                  Content current as of:
      07/28/2016FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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