Web portal makes it easier for non-industry stakeholders to request meetings on development and safety matters but might sow confusion for some patient groups, particularly when it comes to externally led patient-focused drug development meetings.
A new US FDA new system aimed at streamlining meetings between Center for Drug Evaluation and Research staff and external stakeholders reflects the agency's emphasis on ensuring that drug development and regulatory decision-making is centered on patients.
However, some worry the new portal will be a source of confusion, particularly for newer patient groups trying to navigate...
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.
