This
guidance also provides recommendations on the submission of a supplement to a
licensed 351(k) biologics license application (BLA) seeking to add a condition
of use that previously has been licensed for the reference product to the
labeling of a licensed biosimilar or interchangeable product, including
considerations related to the timing of such submissions.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
No comments:
Post a comment
Pharmaceutical Microbiology Resources