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.
PharmTech Talk » FDA Inches Towards a Biosimilar Approval Pathway.
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
As stated in the previous post, we're edging closer to getting a functional biosimilars process in the US to bring this important new class of drugs to the market.
Posted by Bruce Lehr Dec 12th 2011
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