Formalized meetings with regulatory agencies are needed for both drugs in development and to respond to post-marketing questions to maintain and develop existing drugs. They are needed to reach common agreements between regulators and industry regarding the design of development programs, resolving specific issues, and ultimately obtaining timely no-objection of starting clinical trials or product licenses which will be of benefit to both the business and patients. With previous experience, the experts at BLA Regulatory can determine issues of critical importance to the FDA and advise our clients on appropriate strategies to meet the challenges they face. Our past interactions with the FDA include teleconferences, face-to-face meetings, and written correspondences with a wide array of FDA offices and divisions. Our experience extends to:
- Type A Meetings
- Type B Meetings (pre-IND, pre-NDA, pre-BLA, Breakthrough Therapy Designation)
- Type B (EOP) Meetings (end-of-phase 1, end-of-phase 2 or pre-phase 3)
- Type C Meetings
- Mid-cycle and Late-cycle Review Meetings
- Advisory Committee Meetings
- Biosimilar User Fee Meetings (BIA, BPD2, BPD3, BPD4)