Life Science Connect – Now that the 21st Century Cures bill has been signed into law, following a journey that included a fair number of detours and roadblocks, all eyes in the drug development world are shifting to FDA.  To the question “What now?”  FDA can answer: A great deal of work.

The Cures law is loaded with new requirements and deadlines for FDA to meet. In this article, Catalyst President Nancy Bradish Myers reviews five major provisions that biopharma, combination product, and advanced therapy companies will need to analyze and incorporate into their business strategies:

  • Patient-focused drug development
  • Regenerative medicine
  • Real-world evidence
  • Combination products
  • Qualification of drug development tools


In addition to highlighting the major implementation requirements in these areas and what they mean for FDA, the article includes a timeline laying out this implementation flow over the next five years.

Ms. Myers also notes that with the Trump Administration taking the reins in January, some of the Cures implementation flow and cadence will be influenced in ways that will be revealed if and when a new FDA commissioner is nominated.

“As the folks at FDA wrap up 2016, I know what they will be wishing for in the New Year: more bodies,” she concludes. “Since the Cures legislation explicitly allows the Commissioner to make pay scales more competitive and improve the hiring process, hopefully it will allow the agency to more easily recruit and retain top talent to help shoulder the implementation workload.”