Submit a follow-up report

One of the benefits of creating a Portal user account is that you are able to conveniently submit a follow-up report Submitted in order to present new, additional, or amended, information about a previously submitted report. (May sometimes be referred to as a supplemental report.).

 Please note:  Follow-up reporting as a guest user is available only for certain reports. You must log in to follow-up on reports that are submitted under your user account.

A follow-up report is submitted to provide amended or additional information Information requested or received following the receipt of the initial report. This information is "supplemental" to initial submission. (See "Follow-up Report") about an event Construed as including all adverse events, product problems/complaints, and product-use errors. that has already been reported, particularly if the event was serious and unexpected.

You might have obtained more information about an event and wish to report it, or you may have been contacted by a Government representative, such as the US Food Articles used for food or drink for humans or other animals, chewing gum, and articles used as a component of any such article. and Drug (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement. [Refer to: Sec. 201. [21 U.S.C. 321], Chapter Ii—Definitions 1] Administration (FDA The U.S. Food and Drug Administration). Additionally, manufacturers can be requested by regulators to follow up on a serious-event report that has been received directly from the initial reporter The person that submits the safety report—and for an organization, is authorized to provide information on its behalf., and to respond back to the regulating agency.

Once you submit a follow-up report on a submitted report, the original submitted report is no longer available for viewing in the Submitted Reports Available for Follow-Up list—only the follow-up report will be available for viewing. You should create and save a .pdf of your original submitted report before creating and submitting a follow-up report to that original submitted report. If you begin a follow-up report but do not submit it, your originally submitted safety report will be re-listed in the Submitted Reports Available for Follow-Up list.

To begin a follow-up report:

1. Go to the My Reports page A presentation form displayed by the Portal application that allows the user to interact with the application via an input device (e.g., keyboard, mouse, etc.) in order to perform a function..

2. Find your initial/previous report in your list of “submitted” reports. Click the button next to the report for which you wish to submit a follow-up.

3. Click the Start Follow-up button that activates beneath the Submitted Reports Available for Follow-Up list.

4. Information from your previous report will have already populated the follow-up report form. Proceed to modify existing information and add new information as necessary.

 Please note:  When you are offered to name your report and provide a description of it, include a meaningful title and date or sequence number to help you recognize which reports are related in your Draft Reports/Submitted Reports Available for Follow-Up lists.

5. Complete and submit your report as you did for the original Safety Report.

6. If you are a guest user following up on a previously submitted report, on the New Guest Report page, click in the Enter the Report Identification Key and type in the identification key for the report.

See related Help topics:

• Save an electronic copy of your Safety Report

• Find a saved report

• Submit your report