Elizabeth Miller, Associate Commissioner for Inspections and Investigations, provided an update on the FDA’s Office of Inspections and Investigations (OII). She noted that the government shutdown has impacted the OII’s core activities which include inspections, investigations and imports. She noted that the lapse in appropriations has resulted in the need for risk-based prioritization of OII’s activities to include:
- Inspections to safeguard human life
- For Cause Inspections
- Pre-Approval Inspections
- GDUFA Funded Surveillance Inspections
- Inspections funded by other user fee sources
- Other investigational activities as necessary to address imminent threats to the safety of human life
She also discussed the recent reorganizational shift back to a more generalized inspectorate which we previously blogged about (here) and its impact on OII that is designed to provide for a more flexible workforce deployment. The revised program will focus on revolutionizing training to provide a tiered investigator pathway, modernization of the OII training platform, expanding the utilization of technology and provide a continuous learning opportunity for inspectors and staff.
Later in the day, Captain Vincent Sansone, Director of the Division of Project Management, provided a discussion on generic drug assessment communication mechanisms and strategies to facilitate timely approvals. He stressed that the Agency recognizes industry’s need for timely information to assist them in planning for their business operations. He discussed the transparency pilot program to address the informational ‘black hole’ that sometimes develops when there are important scientific issues that arise during the review process that impact the Agency inability to provide specific information to sponsors about a complex regulatory issue. One example includes the nitrosamine issue. However, because of the potential negative impact on the applicants, the Agency has initiated the communication pilot with the purpose and objective to convey more information when complicated regulatory or scientific issues arise. He noted that while many times the specific details of the specific issue may not be able to be discussed, the Agency will attempt to provide reasonable estimated timelines for resolution of the complex regulatory issues. Considerations and elements incorporated into information conveyed to applicants will be based on the following:
- Has the information related to the issue been shared publicly
- Potentially affected discipline(s)
- Is the information specific to a single ANDA or all ANDAs for a given RLD
- Does the Agency need more information from the applicant(s) to use in making the decision
Sansone also discussed the standard communication mechanisms utilized by OGD including complete response letters, information requests, discipline review letters, as well as the opportunities for telecons and meetings that can occur at various touchpoints in the application review process.
Well, that’s it for now. We will be back with more highlights from the GRx-Biosims meeting later in the week.
