US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons calculus for the patients described in a drug's label. While not a new policy perse, it is one the agency seems to have only grudgingly employed in the past.
The US Food and Drug Administration highlighted its ability to incorporate broader public health considerations into its risk-benefit assessments in a new draft guidance on how considerations of a drug’s benefits and risks factor into FDA’s approval decisions and post-market regulation of drugs and biologics.
“In certain circumstances, such as in the review of drugs to diagnose and treat communicable diseases or drugs identified as...
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.
