FDA final guidance maintains limit on secondary endpoints allowed for trials, which could dissuade some investment in research for NDAs for smoking cessation products. NRT developers could find more room for novel product proposals from changes to some phrasing.
The US Food and Drug Administration’s final guidance on clinical trials for smoking cessation or related indications largely mirrors the draft industry stakeholders described as leaving little room for approvals of novel NRTs, though changes to some phrasing in the document could offer some relief.
The Center for Drug Evaluation and Research’s guidance announced on 28 April reiterates its expectation for multiple clinical trials...
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.
