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Lawmaker weighs in on Gottlieb switch to industry
https://pharmaphorum.com/news/lawmaker-weighs-in-on-gottliebs-switch-from-fda-to-industry/
regulatory
eRegulatory Summit
Telematics, RIM, eCTD, IDMP and Filing Variations
2018 Off-Label Regulatory Compliance Congress
Explore the Ever-Changing Regulatory Landscape
Can parallel distribution and industry work together?
Can parallel distribution and industry work together?
Innovative Regulatory Pathways Summit
Disease education to resonate with patient & provider
The EMA’s Adaptive Pathways: are safety concerns exaggerated?
Companies still need to provide a compelling case for efficacy
Samsung Bioepis’ Remicade rival approved in EU
Merck, Sharp and Dohme’s (MSD) inflammatory diseases blockbuster Remicade (infliximab) faces further biosimilar competition after Samsung Bioepis’ rival, Flixabi, was approved in Europe.