Electronic Submissions to the FDA

GOOD MANUFACTURING PRACTICE (cGMP) US FOOD AND DRUG ADMINISTRATION (FDA)
1

The following activity needs to be performed ( to the FDA).

a. Drug Establishment registration and drug listing (Structured Product Labeling)
b. Submission of electronic document through Electronic Submission Gateway (ESG)

Did the above-mentioned activity can be performed through FDA website or we need to purchase the specified software for the submission.

Note: Is it possible to update the Site Identification details also through FDA site.

Did any simplified procedure is available for the above-mentioned activity?

2

Both are done via FDA’s webpages. The ESG requires that you install and test a FDA developed software before you can use the gateway.