Sponsors lack comprehensive advice on how to access benefits of GAIN legislation's incentives, which include the opportunity for fast track designation, priority review designation and five years of market exclusivity, government watchdog says.
After reviewing the actions the US FDA has taken to encourage development of new antibiotics over the last four years, the US Government Accountability Office (GAO) concluded that the agency should issue specific guidance on its qualified infectious disease product (QIDP) designation.
In a report, GAO also recommends that the agency clarify how drug sponsors should use draft guidance documents...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
