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Accelerating US Regulatory Approval for Drugs and Biologics that Treat Serious Diseases

offer-whitepaper.jpgFDA’s Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations can reduce product approval timelines if pursued and implemented appropriately. Taking the time to understand the requirements and potential benefits of each acceleration mechanism will help you make informed decisions about what’s best for your product development program.

You will learn:

  • The difference between Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations
  • Strategies to determine which designation, if any, is right for your program
  • FDA expectations and requirements for each designation