Risks and benefits of FDA's fast-track approval

• In: Biological drugs and gene therapy - Hot topics on regulation and policies affecting use on Tuesday, 4 September 2018, 9:00-12:00
• At: Glasgow (Scotland) (2018)
• Type: Presentation
• By: JAIN, Prateek (Decision Resources Group, India)
• Abstract:

  The US Food and Drug Administration (FDA) has been pushing new therapies to the market faster than ever. There are four expedited pathways; fast-track designation, accelerated approval, priority review, and breakthrough therapy designation (BTD). These processes facilitate the drug development by expediting the review process by cutting down the

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