In addition to the FDAs plan to solicit pharma input on proposed user fees for biosimilars, the FDA has also published proposed performance goals and procedures for the review.
The draft performance goals outline the following:
- timelines for review of applications
- timelines for review of proprietary names
- procedures for resolving disputes.
- the procedure a sponsor should follow to get specific questions answered about protocol design, or about scientific or regulatory questions pertaining to their submission
- timeline for the agency’s response.
- there is an explanation of the types of meetings the sponsor should schedule with FDA
- the information required by FDA before scheduling the meeting
- the timeline or conditions during the submission process that would require scheduling each type of meeting
Posted by Bruce Lehr Dec 12th 2011