If you remember the BACPAC and SUPAC guidelines of the early 1990s, withdrawn by FDA a few years back, and you really wished for a new definitive guideline of what post-approval changes can be relegated to an annual report rather than needing FDA's pre-approval or CBE-30; then attached please find an FDA guideline that exactly fills your needs. It is a draft guideline just issued by FDA for comment, but it is a start and indicates whether FDA thinking is headed.
We at Globepharm strive to keep current with FDA and other world-wide regulatory developments, such that we can provide definitive guidance to our clients on GMP related issues. If we can provide assistance to you or your company, either as GMP-related consulting and training or by acting as your US regulatory agent; we would be delighted to assist you. Please contact me at the below phone or fax or e-mail to discuss your needs.
With Best Regards,
313 Pine Street (Ste 204)
Deerfield IL 60015, USA
Ph: USA +1 847 914 0922
Fx: USA +1 847 914 0988
Attachment :New FDA Draft Guideline - CMC Post Approval Changes