Orphan Druganaut Blog
Bookmark this page for update statistics and list of companies which have publicly disclosed receiving Breakthrough Therapy designation.
Positive Publication Bias IS Harmful
Compilation of Biotech / FDA / Regulatory / Drug Development RSS Feeds
Federal Register Tracker for the Life Sciences
Two great new comprehensive resources from Alec Gaffney to bookmark.
A Watershed For Biosimliars: EU Recommends Copies Of Remicade
Ed Silverman (Pharmalot)
Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics
Food and Drug Administration (FDA)
The much anticipated explanation of, and guide to, Breakthrough therapy, fast track, accelerated approval, and priority review.