FDA orphan drug grants
Agency announced in the Jan. 10 Federal Register that it anticipates availability of funds in FY 1986 for 20-30 grants ranging from $20,000 to $70,000 for orphan product clinical trials. Applications must be received by March 11. The earliest beginning date for awards is August 1. Applications should be obtained from and submitted to Kathryn McKnight, State Contracts and Assistance Agreements Branch (HFA-520), FDA, Room 15A-17, 5600 Fishers Lane, Rockville, MD 20857, 301/443-6170.
You may also be interested in...
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”