Regulated Product Submission Release 2 (RPS R2) Storyboards

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Regulated Product Submissions | RPS R2 Project | RPS R2 Storyboards

Draft Storyboards

C. Two Way Communication Storyboards

The storyboards presented in this section related to the two-way communication between Regulatory Authority and Regulated Industry.


C.1 Send [[Correspondence (RPS)|Correspondence]

Regulatory Authority A (RAA) has reviewed a [[Submission (RPS)|submission] and its components and has a set of questions for the ABC Device Company regarding their [[Product (RPS)|product] 123 and the information provided about their patient and physician labeling. RAA sends the document, which includes their questions to the ABC Device Company and identifies a correspondence type and identifier, related submission identifier, product information, and regulatory contact information.

C.2 Send a Response to Correspondence

Note: This storyboard will extend the Release 1 storyboards for the submission units sent to the regulatory authority. Also, see E.1 for additional information that is required for submission units in general.

ABC Device Company has addressed the questions presented by RAA about their patient labeling and instructions of use documentation. ABC Device Company sends a response to RAA with the appropriate changes to existing documentation and provides a response to the original correspondence, identifying the originating correspondence identifier, related submission identifier, product information, and regulatory contact information. Two weeks later, ABC Device Company has been able to address the questions that the RAA posed in regards to physician labeling. ABC Device Company sends a second response to the first correspondence from the RAA to add new documentation, update existing documentation and provide a response to the original correspondence, identifying the originating correspondence type and identifier, related submission identifier, product information and regulatory contact information.

D. Referencing

TBD


E. Extending Information about in a [[Submission Unit (RPS)|Submission Unit]

This section is extending Release 1 storyboards and the information about the submission to aid either the Regulated Industry or Regulatory Authority with the two-way communication storyboards. Either party can utilize the information about the submission to determine secondary processing of the message.


E.1 Additional Information about a [[Submission Unit (RPS)|Submission Unit]

Acme Pharmaceuticals is sending RAA a submission unit and identifies the contact information for the submission (e.g., any points of contact name, address, phone, email, fax), product information (e.g., product name, product code, product code set), Regulatory Authority information (i.e., Agency, Center), submission information (e.g., submission number, serial number, sequence number, presubmission identifier), application information (e.g., category and sub category).