FDA published meeting minutes from its Biosimilar User Fee Act (BsUFA) reauthorization meeting on 12 May with industry representatives, including the Association for Accessible Medicines, the Biotechnology Innovation Organization (BIO), the Biosimilars Forum, and PhRMA
All TUEs are dealt with on a case-by-case basis and whenever possible aims to take a common-sense approach to TUEs
Saxenda has not been studied in patients taking insulin
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