CDER Takes A Micro/Macro Approach To Monitoring ‘Breakthrough’ Programs
Agency staff will conduct high-level reviews every three to six months to assess adequacy of individual development programs, while the Medical Policy Council will undertake portfolio reviews across breakthrough-designated products.
You may also be interested in...
CDER Manual of Policy and Procedures describes specific actions FDA review staff will take once a product has received “breakthrough therapy” designation, with an emphasis on more meetings, more frequently.
FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.