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  • MedWatch: FDA Safety Information Adverse Event Reporting Program
    MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers Report a Problem Safety Information Stay Informed MedWatch receives reports from
  • MedWatch Forms for FDA Safety Reporting
    Safety reporting portal for health professionals, patients, consumers and industry Find pdf fillable forms in English and Spanish and a link to report safety concerns to the FDA online
  • Reporting Serious Problems to FDA
    MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence failure, and product use errors with human medical
  • Reporting Adverse Events to FDAs MedWatch Program
    An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe
  • Manufacturer and User Facility Device Experience (MAUDE) Database
    The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers
  • FDA MedWatch Medical Product Safety Information
    MedWatch alerts provide timely, actionable safety information on human drugs, medical devices, biologics, dietary supplements, and cosmetics
  • Subscribe to MedWatch Safety Alerts | FDA
    MedWatch safety alerts delivered to you Clinically important medical product safety alerts and timely information about the drugs and devices you use, prescribe, or dispense every day, delivered
  • Safety Reporting Portal
    For both consumers and industry submissions, please use the Safety Reporting Portal for electronic dietary supplement related reporting Here are additional ways to submit safety issues: If you are a consumer, patient or healthcare professional, Call a CVM Complaint Coordinator at (301) 796-2428 If you are a manufacturer, distributor or packer, Go to the FDA's MedWatch 3500A Form instruction
  • Forms | FDA
    Listing of all external Forms both OMB approved and state using ORA forms
  • Instructions for Completing Form FDA 3500
    Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer patient) to MedWatch: The FDA





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