Drug Safety Standards

Drug Safety Standards

Provider: UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES - U S FOOD AND DRUG ADMINISTRATION

The Food & Drug Administration (FDA) is working with the medical industry to develop vaccines, drugs, and diagnostic tests.

Vaccines: The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory, clinical and manufacturing data to ensure the safety, effectiveness, and quality of these products. Additional information is available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions#biologics

Information regarding the Johnson & Johnson / Janssen COVID-19 vaccine which was approved February 28th, 2021 is available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/janssen-covid-19-vaccine-frequently-asked-questions

FDA Approved Drugs & Medicines: Visit link below for information about FDA approved drugs:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions#drugs

Medical Devices Including Tests for COVID-19: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions#devices

FDA General FAQs https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19-frequently-asked-questions

Fraudulent Products The FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. A list of identified products is available at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products . You can report websites selling fraudulent medical products to the FDA through its website https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet APPLICATION PROCEDURE See Information Above FEES/PAYMENT SOURCE Not Applicable
Application Procedure

Service/Intake

(888) 463-6332 (1-888-INFO-FDA (General Info./Reports)) (888) 723-3366 (Safe Food Info Line - 10am to 4pm, EST)

Emergency

(866) 300-4374 (24 Hour Emergency Operations)

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