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Drug Reporting Resources

Safety Reporting Portal (HHS SmartHub)

Safety Reporting Portal (Submit a Report)

Safety Reporting Portal (Submit a Report)

 A federal reporting tool that empowers individuals to report side effects, safety concerns, and issues with FDA-regulated products. By sharing real experiences, patients and caregivers help increase transparency, raise awareness, and push for accountability in healthcare and drug safety. 

Visit Reporting Portal

Safety Reporting Portal (Submit a Report)

Safety Reporting Portal (Submit a Report)

Safety Reporting Portal (Submit a Report)

 The official federal submission page where individuals can directly report adverse events, side effects, and product concerns. Reports can be submitted with or without an account, making it easy for patients, caregivers, and professionals to contribute to safer, more transparent healthcare. 

Submit a Safety Report

Transparency and Accountability Tools

U.S. Drug Labeling and Misbranding Law

U.S. Drug Labeling and Misbranding Law

U.S. Drug Labeling and Misbranding Law

U.S. law that requires drugs and medical products to have accurate labels, clear directions, and truthful claims to keep consumers safe. 

21 U.S. Code § 352 - Misbranded drugs and devices

Open Payments Data (CMS)

U.S. Drug Labeling and Misbranding Law

U.S. Drug Labeling and Misbranding Law

 A public U.S. government database showing reported payments and financial relationships between drug/medical device companies and healthcare providers, designed to increase transparency in the healthcare system. 

View Payments Data

FDA Instructions for Submitting Citizen Petitions Electronically

FDA Instructions for Submitting Citizen Petitions Electronically

FDA Instructions for Submitting Citizen Petitions Electronically

Guidance from the U.S. Food and Drug Administration on how to electronically file Citizen Petitions and related materials through the federal docket system at  Regulations.gov. 

Learn How to Petition

Federal Rulemaking Portal

FDA Instructions for Submitting Citizen Petitions Electronically

FDA Instructions for Submitting Citizen Petitions Electronically

The U.S. government’s central online hub for searching, viewing, and commenting on open federal regulations, notices, and dockets from participating agencies. 

https://www.regulations.gov/

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