Brad Thompson says that phone calls used in current informal process help sponsors understand Office of Combination Product’s thinking, and that a formalized process envision in the new draft guidance could make this dialogue more difficult.
The US FDA’s new draft guidance for combination product sponsors on how to prepare a Pre-Request for Designation (Pre-RFD) may in fact be a step backwards in terms of convenience and value for developers compared to the current informal process, according to one expert.
Brad Thompson, an attorney with Epstein Becker & Green, tells the Pink Sheet that the current informal process of calling...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
