How do I create a WebTrader account?
Setting up a WebTrader Account Checklist
- Send an email to [email protected] requesting a WebTrader test account. ...
- Send a hard copy Letter of Non-Repudiation to the FDA. ...
- Obtain a personal digital certificate from a CA or create one using our certificate generation tool .
What is WebTrader account?
WebTrader is a Web interface that copies and packages your submission on your desktop in a secure fashion, transmits the submission in a fully encrypted message to the FDA, and then removes any traces of its presence from your PC. For policy questions and to request a WebTrader account, contact [email protected].
What is the FDA ESG?
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.
Where can I get a FDA submission?
FDA does not recommend specific tool vendors, however, they can be located via internet search. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at [email protected] or CBER at [email protected].
How do I find FDA approved products?
To find out if a drug is approved by FDA, consumers can use two different Internet sites:
- Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. ...
- The FDA "Orange Book" contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
What is FDA Gov?
U.S. Food and Drug Administration.
How do I contact the FDA?
Contact FDA
- Call: 1-888-INFO-FDA. (1-888-463-6332)
- Email: See Contact FDA Centers and Offices below or search the employee directory.
- Write to: Food and Drug Administration. 10903 New Hampshire Ave. Silver Spring, MD 20993-0002.