FDA Gives Innovation, Harmonization Added Attention In Final Priorities Report
This article was originally published in The Gray Sheet
The agency made subtle but potentially notable changes from a draft in its final five-year strategic priorities document, released Sept. 30.
You may also be interested in...
“Given the limited availability of investment capital for medical product development, early clarification of regulatory requirements is critical,” FDA says.
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
AbbVie is to terminate the clinical development of lemzoparlimab for myelodysplastic syndrome and acute myeloid leukemia and will also reduce the size of its 2020 deal with originator I-Mab by $445m, in the latest blow to the Chinese firm.