Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?
Executive Summary
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
You may also be interested in...
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.
Next US FDA Generics Leader Must Have ‘Frank Conversations’ With Colleagues, Industry, Former OGD Director Says
Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’
GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.