Regulated Product Submission Release 2 (RPS R2) Storyboards

Regulated Product Submissions | RPS R2 Project | RPS R2 Storyboards

Draft Storyboards

C. Extending Information about 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.

C.1 Additional Information about a Submission Unit

Example 1: Send Submission Unit to Regulatory Authority

Acme Pharmaceuticals is sending RAA a submission unit to provide the final labeling for their marketing application and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), Regulatory Authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category and sub category) and Comment field (free text description).

Example 2: Send Submission Unit to Regulated Industry

The RAA is sending an interim action to place the investigational study on hold, the correspondence type would be Interim Action/Clinical Hold, and identifies the contact information for the submission (e.g., any points of contact first name and last name, Contact Type, address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application number, regulatory authority submission number, sequence (serial) number, presubmission identifier), Submission Unit Type (e.g., category and sub category)and Comment field (free text description).

Example 3 (occurs prior to D5 and E5): Send a Reviewable unit to Regulatory Authority (Devices

Device Company ABC submits the first of three modules(***) of a modular Premarket Approval (PMA), a reviewable unit, to the FDA/CDRH for Product Implant 123, including the the contact information for the submission (e.g., any points of contact first name and last name, type of contact (*), address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit (****) number, sequence (serial) number, presubmission identifier), submission unit type (**)(e.g., category and sub category) and Comment field (free text description).

Example 4 (occurs prior to D5 and E5): Send a Submission unit related to a Reviewable Unit to Regulatory Industry (Devices)

FDA/CDRH sends questions about three modules (***) submitted for Product Implant 123, including the product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority submission number, regulatory authority reviewable unit(****) number(s), sequence (serial) number, presubmission identifier), submission unit type**(e.g., category and sub category)and Comment field (free text description).

(*) Type of Contact – To indicate the type of contact (e.g., Regulatory Affairs Specialist, Technical Contact, Regulatory Project Manager, Lead Reviewer, Scientific Lead, Division Director, etc.)

(**) Submission Unit Type – the type of submission unit (package) being sent by either party. This may be the Correspondence Type and subtype (e.g., Action Letter/Approval or Meeting Request/Manufacturing) or Submission Type (e.g., Carcinoginicity Protocol/Special Protocol Request or Labeling/Final Labeling).

(***) the modules in this example are not synonymous with the modules of an eCTD

(****) at this point, an application number is not supplied by the regulatory authority

C.2 Modify Information about a Submission

Example 1: Modify Information about a Submission by Regulated Industry

Pharma ABC has changed ownership and needs to update the contact information for five of their submissions under review. They send a cover letter indicating the change of contact information and the affected submissions, and identifies the contact information for the submission (e.g., any points of contact first name and last name, type of contact (*), address, phone, email, fax), product information (e.g., product type, product name, proper name, trade name, product code, product code set), regulatory authority information (i.e., Agency, Center), submission information (e.g., regulatory authority application number, regulatory authority submission number, sequence (serial) number, presubmission identifier), submission unit type (**) (e.g., category and sub category).

Example 2: Modify Information about a Submission by Regulatory Authority

RAA has received a BLA amendment from BioPharm Co for a product 123 that is under review, the information provided in the submission indicates that a new supplement should have been submitted. The RAA send an update to the submission unit back to the BioPharm to indicate that the submission number has been changed and reassigned a new submission number and sequence number.

Note: This storyboard needs to be validated – this is for the simple situations where something can be reclassified without the submission being resubmitted. This would not handle a situation where the company would need to restructure the contents of their submission because the content was not accurate for the new submission type.

D. Two Way Communication Storyboards

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

D.1 Send Correspondence

Note: A correspondence is considered a submission unit, and therefore may identify the relevant information about a submission outlined in Section E of the Storyboards.

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 2a: Action or Decision Notification

Regulatory Authority A (RAA) has reviewed a 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 2b: Action for Example D.2.1b (see below)

FDA/CDRH approves 5 PMA supplements after review the changes to the manufacturing site and sends an approval letter to the ABC Device Company indicating the correspondence identifier and the five affected PMA supplement number. In a week, the other 10 PMA supplements are approved after reviewing the manufacturing change submission and send an approval letter indicating the correspondence identifier and remaining affected 10 PMA supplement numbers.

Example 3: Request for a Meeting by the Regulatory Authority

Regulatory Authority A (RAA) has reviewed a 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.

Example 5: Send request for additional information to more than one reviewable unit within an application

FDA/CDRH sends Device Company ABC a letter containing questions that relate to modules 1-3 of Product Implant 123’s modular premarket application (M089999), and they indicated a correspondence identifier.

D.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 1a: Send Response to 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.

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 identifier.

Example 1b: Send Response to Request for Additional Information

ABC Device Company is responding to questions received about a sterilization changed for a submission that is currently under review. The company submits a manufacturing change submission unit that pertains to all affected products, which includes 15 PMA supplement submissions under 5 different PMAs (i.e., applications). The documentation provided in the this response will apply to all 15 PMA supplements

Example 2: Response to an 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 identifier.

Example 3: Response to a Request for a Meeting by the Regulatory Authority

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 identifier. 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 identifier.

Example 4: Response to a Request for a Meeting by Regulated Industry

The RAA responds to the meeting request received from Vaccines.com to accept one of the proposed meeting times and identifies the originating correspondence identifier.

Note: This storyboard is an example of presubmission activities, but there are other examples that would happen within a review cycle. Would this storyboard (pre-submission) require any special information?

Example 5: Send Response to request for additional information to more than one reviewable unit within an application

Device Company ABC responds to correspondence regarding the questions for module 1-3 from the FDA/CDRH by sending one document, which addresses all of the questions about the three reviewable units.

E. Referencing

TBD