The Center for Drug Evaluation & Research has “turned the corner” on net gains in staffing during the past year, acting CDER Director Patrizia Cavazzoni said during a briefing hosted by the Alliance for a Stronger FDA on 16 October.
US FDA Drug Review Hiring Doing Well Despite Pandemic
CDER has ‘turned the corner’ on hiring during 2020, acting Director tells stakeholders – though the added workload from COVID-19 makes that hard to see.
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One CDRH employee said the cuts already are having a major effect on morale.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.
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South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.