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Alekhya Bethi
Voluntary
Reporting to FDA:
Reporting by Consumers
Reporting by Health Professionals
evaluation might include Epidemiology Studies. Based on these reports FDA takes regulatory actions.
ACTIONS
LIMITATIONS
Updating
label info Restricting the use of the drug Communicating new safety info Removing a product
No
certainty that the reported event was actually due to the product. Not every event is reported. Duplicate reporting occurs.
MEDWATCH
The FDA Safety Information and Adverse Event Reporting Program. Protecting the public health by assuring the safety, efficacy, and security of human ... drugs, biological products, medical devices, cosmetics, and products that emit radiation.
Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
What All clinical medical products When If serious How Online, or mail/fax/phone Why Every report can make a difference
Drugs
Prescription Over the Counter
Cosmetics
Online
www.fda.gov/medw atch
Phone
1-800-FDA-1088
Fax
1-800-FDA-0178
Report captured in a database Database monitored by an FDA professional Review of a case series Consultation with medical review division and manufacturer Further epidemiological studies as needed
QUESTIONS
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