CHPA's 2020 project is an internal analysis on how it can evolve as its members broaden into additional business categories. President and CEO Scott Melville says the effort is necessary to keep up with the “lightning speed” of health care changes.
The Consumer Healthcare Products Association is conducting an “inward analysis” on potentially expanding membership opportunities to firms in additional product categories where current members increasingly are extending their businesses.
“Health care, especially consumer health care, is evolving at lightning speed, and so too, must CHPA,” said President and CEO...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
