FDA Responds to Nagging Questions About “Lagging” Drug Review Divisions
This article was originally published in RPM Report
Executive Summary
It’s a question FDA has heard on Capitol Hill throughout the 21st Century Cures process: Why can’t all drug review divisions keep pace with the approvals seen in the oncology office – and shouldn’t steps be taken to ease development pathways for “lagging” conditions like Alzheimer’s and rare diseases? In the face of a tougher “Cures” debate in the Senate, FDA issues a white paper to more fully outline its response.
You may also be interested in...
Alzheimer’s Drugs Take Baby Steps Toward Brighter Future
Anti-beta amyloid antibodies from Lilly, Biogen Idec and Roche took center stage at the recent Alzheimer’s Association International Congress, but as a new PhRMA analysis shows, getting to the development finish line is rare – with 30 failures for every one success.
Blame The Science, Not Regulation, For Targeted Therapy Shortfalls – FDA
In a report both boastful and defensive in tone, the agency explains why some disease areas are rife with targeted therapies while others have few or none.
FDA Outlines “Expedited” Review For Breakthrough Therapies; “Hyper-Fast” Reviews, Beyond Oncology
Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.