Is Even The Pharma Industry Over COVID-19 Already?
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.
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FDA trial design criteria pose challenges for new COVID therapeutic development, frustrating companies and NIH and prompting a tense meeting earlier this summer, according to audio obtained by the Pink Sheet.
CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
Peter Marks predicts that staffing challenges within CBER can be alleviated by offering employees the flexibility to work remotely – permanently. With important posts in the vaccines office still to be hired, it could be an important incentive.