Regulated Product Submission Release 2 (RPS R2) Storyboards

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

Example 1: Request for Additional Information

Regulatory Authority A (RAA) has reviewed a submission and its components and has a set of questions for the ABC Device Company regarding their 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 identifier.

Example 2: Action or Decision Notification

Regulatory Authority A (RAA) has reviewed a [[Submission (RPS)|submission] and needs to communicate an interim or formal action through a decision letter to inform Acme Pharmaceuticals about their action regarding the regulated activity (e.g., investigational or marketing applications) for Product 999. RAA sends the document, a decision letter, which includes the status of the regulated activity (e.g., approved, non-approvable, clinical hold) and identifies a correspondence identifier.

Example 3: Request for a Meeting by the Regulatory Authority

Regulatory Authority A (RAA) has reviewed a [[Submission (RPS)|submission] and its components and would like to clarify some questions via a meeting with Acme Foods regarding the SweetSugarCane product. RAA sends a document, a meeting request, which includes the details of the meeting request and identifies a correspondence identifier

Example 4: Request for a Meeting by Regulated Industry

Vaccines.com would like to request a meeting with the RAA as they have just come into the marketplace and would like to meet with the regulators prior to submitting an investigational or marketing application. The company would like to discuss their manufacturing facilities and sends a document, the meeting request, which includes the details of the meeting request and identifies a correspondence identifier.

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.

Example 1: Request for Additional Information

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.

Example 2: Action or Decision Notification

Acme Pharmaceuticals sends a response to RAA to address a clinical hold action for Product 999 with the appropriate changes to existing documentation (and/or additional documentation) and provides a response to the original correspondence, identifying the originating correspondence type and identifier, related submission identifier(s), product information, and regulatory contact information.

Example 3: Request for a Meeting

Acme Foods has reviewed the meeting request to discuss the SweetSugarCane product and sends a response, in the form of documentation, to the RAA to accepted one of the proposed meeting times. Acme Foods also provides an identifier to the originating correspondence type and identifier, related submission identifier(s), product information, and regulatory contact information. In preparation for the meeting, Acme Foods has been asked to prepare pre-read materials regarding their manufacturing practices. Acme Foods sends this documentation to the RAA in advance, providing the original correspondence type and identifier, related submission identifier(s), product information, and regulatory contact information.

D. Referencing

TBD

E. Extending Information about in a 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

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).