Biotech Translations

The biotech industry is almost as bad as the military when it comes to finding an acronym for everything and making sure nobody except insiders can understand. Below find a list of common terms and their definitions. This section is constantly under construction. Every time I come across something that I have to look up I will add it here.
 
FDA Terms- In order of a drug's pathway to market
  • BLA - Biologic(s) License Application
  • CRL- Complete Response Letter. This is not the kind of mail that a drug company wants to receive. The FDA sends a CRL when they are rejecting a new drug or biologic application
  • FDA -The Food and Drug Administration. These are the guys and gals who's decisions can make an investor cry or jump for joy. Their approval makes and breaks new drugs and the companies developing them
  • IND - Investigational New Drug Application
  • IDE - Investigational Device Exemption. Essentially the same as an IND, but for medical devices.
  • NDA - New Drug Application
  • Orphan Drug
  • PDUFA
  • PDUFA Date
  • SPA - Special Protocol Assessment
European Drug Approvals-The EU has a similar, but not identical system for drug approvals. And just to keep things interesting they have a different name for everything.
 
  • CE Mark
 
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