1. Formal Meetings between FDA and Sponsors of PDUFA Products
Natalia Shunmugan PhD Manager Regulatory Intelligence
Gilead Sciences Inc.

2. Overview
On March 11, 2015, FDA published a draft guidance titled “Formal Meetings between the FDA and Sponsors or applicants of PDUFA products
The new draft guidance makes RELATIVELY FEW CHANGES:
2009 draft guidance has 12 Titles, 2015 draft guidance has 11
Set within framework of PDUFA V, as referenced by “This guidance does not apply to abbreviated new drug applications”
Comments due to FDA by June 9, 2015
– 5 key points changes:

3. What stays the same – more or less….
Item
Type A Meeting
Type B Meeting
Type C Meeting
Meeting Timing
(days after FDA receipt of request)
30 days
60 days
75 days
Meeting designation
Meetings for:
stalled development programs/to address important safety issues
Dispute resolution
clinical holds
SPAs
Pre-IND
Certain EOP1 meetings for sub- part H
EOP2/pre-phase 3
Pre-NDA/BLA
Pre-emergency use authorisation
Post-action meetings
REMS
BTD
Any meeting other than a Type A or Type B meeting re the development and review of a product
Meeting package due date
Must be submitted same time as meeting request
1 month prior to meeting

4. Changes common to all Meetings
Item
2015 Draft Guidance
Type of Change
Agenda
Lines
Proposed agenda must include estimated times for each item to be discussed. Must not exceed total time allotted for meeting
Timed agenda items
Attendees
Lines
Requests for attendance by FDA staff who are not essential, may affect the ability to hold meeting in timeframe requested
Meeting request should state whether or not a later meeting date is acceptable
Communication
Lines
Our goal is to communicate these preliminary responses to the requester no later than 2 days before the scheduled meeting
Previously: “We may communicate these preliminary responses to sponsors”
Scheduling
Lines (Type A)
Lines (Type B)
Lines
If a request for a meeting date that is beyond 30/60/75 days from the date of the request receipt, the meeting date should be within 14 calendar days of the requested date
No longer “earliest agreeable date”

5. Changes to Type A Meeting
Item
2015 Draft Guidance
Type of Change
Meeting Request
Lines
Lines
The Agency will deny requests for Type A meetings that do not include the meeting packages in original request
Meeting package now with request
Also has to be “adequate”
Post-action meeting
Lines
Post-action meeting requested within 3 months after an FDA regulatory action other than an approval (i.e. issuance of a CRL)
PDUFA goal – Also with Type C meeting

6. Changes to Type B Meeting
Item
2015 Draft Guidance
Type of Change
Type B Meeting
Lines
Sponsors can request a written response to pre-IND questions
Written rather than f-f meeting, video or teleconference
The Agency will also inform the sponsor of the date it will send the written response
Lines
Post action meeting requested 3 months or more after an FDA regulatory action other than an approval (i.e. issuance of a CRL)
PDUFA goal
Lines
Meetings regarding REMS/PMRs that occur outside the context of the review of a MA
In the case of BTD – anticipated PMRs/PMCs
Discussion of potential safety issues or potential need for REMS
Lines
Meetings to discuss overall development program for BTD products.
Subsequent meetings for BTD will be considered either Type B or possibly Type A meeting if the meeting request meets the criteria for a Type A meeting
Elaboration on July 2014 guidance
Lines
BTD products will get > 1 of each of the Type B meetings for each application (IND, NDA, BLA)
This is at the Agency’s discretion to grant more Type B meetings to non-BTD products

7. Changes to Type C Meeting
Item
2015 Draft Guidance
Type of Change
Meeting requests
Lines
“… the requester can request a written response to the questions rather than a f-f meeting, video or teleconference”.
Also with Type B

8. Conclusion Five Key changes:
Addition of the written response meeting format for pre- investigational new drug application and Type C meetings
Designation of a post-action meeting requested within 3 months after an FDA regulatory action other than approval as a Type A meeting
Designation of a post-action meeting requested 3 or more months after an FDA regulatory action other than approval as a Type B meeting
Designation of a meeting regarding risk evaluation and mitigation strategies or post-marketing requirements that occur outside the context of the review of a marketing application as a Type B meeting
Inclusion of a meeting package in Type A meeting requests Designation of meetings to discuss the overall development program for products granted breakthrough therapy designation status as a Type B meeting
– 5 key points changes:

9. Thank You