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On Centre-Pharmacovigilance Programme of India) Ministry of Health & Family Welfare Government of India Sector-23, Raj Nagar, Ghaziabad-201002 www.ipc.nic.in A. PATIENT INFORMATION AMC Report No. Worldwide Unique 12. Relevant tests / laboratory data with dates 2. Age at time 3. Sex M F of Event or date of birth 4. Weight Kgs 1.Patient Initials 13. Other relevant history including pre-existing medical conditions (e.g. allergies, race, pregnancy, smoking, alcohol us.

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If you prefer, you may contact the U.S. Food & Drug Administration (FDA) directly. .fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

If you have any concerns about an adverse event it is important to also speak to a health professional. Consumers: report a side effect of a medicine or vaccine - external site using the online form. Health professionals: report an adverse event of a medicine or vaccine - external site.

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

Submitting Adverse Event Reports to FDA Report Online. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. ... Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals. View Instructions for Form FDA 3500.

Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor's initial receipt of the information.

It is important that you also contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine. They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment.

The FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether an event will be reported, such as the time a product has been marketed and publicity about an event.

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 Safety Information and Adverse Event Reporting Program.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232