FDA Breakthrough Therapy Designation Chart
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
Drug Baron
Compilation of Biotech / FDA / Regulatory / Drug Development RSS Feeds
Federal Register Tracker for the Life Sciences
Regulatory Focus
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.
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
Drug Baron
Compilation of Biotech / FDA / Regulatory / Drug Development RSS Feeds
Federal Register Tracker for the Life Sciences
Regulatory Focus
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.
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