More Meetings Mean More Productivity

“D” Is Detailed Advice

Type D meetings will allow sponsors to ask more clarifying questions after a formal meeting.

The meeting is limited to two focused topics and should not require input from more than three disciplines or divisions.
Background packages will be required at the time the meeting request is submitted.
The FDA goal is 14 calendar days to respond to a meeting request and 50 days from the receipt of the request to schedule the meeting or written response.

CDER Will Start INTERACTing With IND Sponsors

Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT) meetings will be formalized for CDER, in addition to CBER, and available for novel questions and unique development challenges prior to IND filing.

IND-enabling toxicology study designs, complex manufacturing technologies or processes, innovative device development for use with a drug or biologic, or a cutting-edge testing method are appropriate topics.
Background packages must be submitted at the time of the meeting request.
The FDA goal is 21 calendar days to respond to a meeting request and 75 calendar days to schedule the meeting or written response.

Post-Marketing Requirements To Be Discussed Earlier

The FDA will communicate details on anticipated postmarketing requirements to sponsors no later than eight weeks prior to the user fee goal date for standard applications and six weeks before the goal date for priority applications.

The agency will be required to meet the goal for 60% of applications in FY 2023, 70% of sponsors in FY 2024, and 80% of sponsors in FY 2025 through FY 2027.
All relevant Manual of Policies and Procedures (MaPPs), Standard Operating Procedures and Policies (SOPPs) and guidances on PMRs must be updated by the beginning of FY 2023 and finalized by the end of FY 2027.
Staff training on updated PMR processes also will begin in FY 2023.
A new formal process also will be established to request the release of a PMR, along with the ability to appeal a non-agreement letter stating a PMR should remain in place.
The process will be incorporated into all FDA MaPPs, SOPPs and guidances by the beginning of FY 2023 and finalized by the end of FY 2027.

Some Applications Will Get To Be STARs

The Split Real-Time Application Review (STAR) pilot program will allow sponsors of qualifying supplements to send application information in two parts about two months apart.

The goal is to shorten the time between the date of a complete submission and the action date.
Application assessments will begin when the first part of the supplement is submitted, but the PDUFA clock will not start until the second portion is received.
The agency also will act on the application at least one month earlier than the goal date.

When It Comes To Sponsor Meetings, FDA Is Getting A ‘D’

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