Policy Development and Guidance

1
Policy Development and Guidance

• Jon Clark
• OPS Associate Director for Policy Development

2
GMP for 21st Century

• Some CMC guidance documents are out of
  synchronization with new thinking
• Guidance process has strong and weak points
• Strength is in technical input from staff
  scientists
• Weakness is in decision making process for drafts

3
Draft cycling
CMCCC Body
Review Teams
CMCCC Body
CMCCCWorking Group
OPS Edit
Legal Edit
Public Comment
4
Time Consuming Process

• Rapid change in FDA thinking
• Leaves slower efforts to catch up
• Guidance development is a slower process
• Investment of Time
• Documents may be slow, but they have momentum
• Guidance Content and New Direction are managed by
  different groups

5
Actions Taken

• Move coordinating and decision making from CMCCC
  working group to OPS Office
• OPS Coordinating Committee (OPS CC)
• Moves Guidance content management to OPS
• Disband CMCCC
• Mandate OPS CC to recruit technical input from
  scientists

6
New Process
Science input from selected Teams
OPS CC
OPS Edit
Legal Edit
Public Comment
7
Synchronization Effort

• Revision of drafts
• Public comment recycle
• Withdrawal of Documents
• Mainly for finalized Guidance documents
• Enforcement Discretion
• Guidance to address regulation requirements

8
Consider Options OTG

• Other Than Guidance
• Question and Answer Format
• Post on public Internet
• Keep it Simple
• Manual of Policy and Procedure (MAPP)
• If/Then format-Directed toward OPS staff
• Publicly available
• More rapid and flexible

9
Guidance

• Risk based approach
• Reverse recent tendency toward proscription and
  prescription
• Manufacturer chooses technology and approach to
  problem solving
• Focus efforts on assurance of reliable product
  quality and not technology

10
Input to Our Processes

• What do you think?
• Is there potential gain from formation of a Fact
  Finding Group to help us determine how we move
  toward the Desired State?
• Do we need all the Guidances?
• Where are they incongruent?
• Provide advice as to what Guidance Industry needs
  as we work toward a new regulatory paradigm.
• Prioritization

11
End