By: Robert McNeill, Ph.D., Scientist
In December 2017, to address changes under PDUFA VI, the FDA published a draft guidance for industry titled Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products (Version date: 18 December 2017) (2017 PDUFA Meetings draft guidance). At the same time, two guidance documents were withdrawn: “Formal Meetings between the FDA and Sponsors or Applicants”, published 19 May 2009 and “Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products”, Revision 2, published 11 March 2015 (2015 PDUFA Meetings draft guidance).
The 2017 PDUFA Meetings draft guidance provides FDA’s recommendations for the formal meetings with the FDA defined under PDUFA VI. As in the previous version, the guidance addresses meetings related to the development and review of drug or biological drug products. This guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices. Although the 2017 PDUFA Meetings draft guidance is similar to the prior draft guidance, there are some important changes:
Content of meeting requests and meeting packages:
- Information required to be included in a meeting request is now defined. For example, a list of requested FDA attendees is now required, and justification should be provided for the request of nonessential FDA staff.
- New details are now recommended to be included in a meeting request and in a meeting package. For example, the proposed regulatory pathway – e.g., 505(b)(1), 505(b)(2) – should now be included in both documents.
Type and format of meetings:
- There are now four defined meeting types: Type A, Type B, Type B (end of phase [EOP]), and Type C.
- FDA specifies that any meeting format can be requested for any type of meeting (i.e. face-to-face, videoconference, teleconference, or written response only). This was limited in the previous guidance.
- Type C meetings can now be held, in some cases, to provide early consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval.
- End-of-phase 2 meetings, pre-phase 3 meetings and certain end-of-phase 1 meetings are now classified as Type B (EOP) meetings, instead of Type B meetings.
- As always, it remains the FDA’s prerogative to decide whether to grant a meeting, the final meeting type, and the appropriate meeting format, and importantly…
- FDA advises sponsors and applicants to contact the review division or office to discuss the appropriateness of a Type A meeting request before submitting a meeting request.
Timelines for formal meetings:
Important timelines are nicely summarized in tables within the 2017 PDUFA Meetings draft guidance. Key information and changes include:
- As before, Type B meetings will be schedule within 60 days of the request with the information package due at least 1 month prior to the meeting.
- The new Type B (EOP) meetings will be scheduled within 70 days of the request with the information package due at least 50 days prior to the meeting.
- For Type C meetings to provide consultations on the use of a biomarker as a new surrogate endpoint to be used as the primary basis of approval, the information package must be submitted at the time of the request.
- For other Type C meetings, the information package must now be submitted at least 47 days before the meeting date (instead of the previous 1 month deadline).
- Preliminary responses from the FDA should now be sent no later than five days before Type B(EOP) meetings and Type C meetings, instead of at least 2 days before the meeting.
- The requester will now have to notify the FDA whether Type B (EOP) meetings and Type C meetings meeting are still needed within three days of the meeting.
Other new information
- More detailed information on the content of FDA’s meeting minutes.
- A request from CDER to bring desk copies of meeting packages submitted electronically to the meeting.
- A statement that CBER does not request nor accept desk copies of electronically submitted meeting packages.
The PDUFA Meetings draft guidance 2017 is an essential document for sponsors and applicants when considering formal communications with the FDA. Adhering to these recommendations will help ensure successful and informative meetings with the FDA for drug and biological drug products. This draft guidance is currently open for public comments until 29 March 2018.