FDA final guidance recommends comparative pharmacodynamic studies for nasal and oral routes of abuse, simplifies statistical approach to show deterrence of generic is same as brand.
FDA has heeded the advice of stakeholders and eliminated its recommendation that manufacturers of generic abuse-deterrent opioids compare the brand to a control product for certain studies.
The agency's draft guidance to assist industry in developing generic versions of approved abuse-deterrent formulations (ADFs) advised that for certain...
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.
