[Presentation] Overcoming Manufacturing Challenges for Accelerated Approvals

The pharmaceutical industry has experienced an upward trend in the number of expedited pathways (i.e. Fast Track, Priority Review, Breakthrough Therapy, and/or Accelerated Approval). These designations are given shortened timelines for product development, product assessment, and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges. Working closely with regulatory authorities and agreeing upon the expected standards for the project can increase the chances for a successful program. Catalent has the expertise and experience in working with accelerated approval programs and know how to handle the manufacturing challenges that present themselves along the development and manufacturing process.

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