Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
The US FDA is finishing guidance explaining a new meeting type for combination product sponsors that will allow pre-submission development agreements – another attempt to smooth the approval process for a sector where historically hurdles often arise.
Agreements are not expected to be binding under the new combination product agreement meeting (CPAM), but could cover a wide...
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.
