JD Supra

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...
Forbes

FDA’s Conditional Approval Plan Would Unleash Biotech Innovation

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a move that could dramatically reshape the landscape for rare ...

Gyre Therapeutics Announces Alignment with China’s CDE on Conditional Approval Pathway and Priority Review Eligibility for Hydronidone Following Pre-NDA Meeting

Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review ...
The Journal

FDA grants conditional approval for New World screwworm drug

On Sept. 30, the U.S. Food and Drug Administration conditionally approved the first injectable drug for the prevention and treatment of New World screwworm in cattle. The drug is produced by Zoetis ...