US FDA Program Streamlining COVID-19 Treatment Development Still Working As Emergency Ends
Any program changes would not occur until after a thorough assessment, the agency said.
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Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.
But some, including some related to inspections and master protocols, will remain in effect to allow for revisions or a transition out of the pandemic posture.
Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.