Pink Sheet Podcast: Roctavian CRL, COVID-19 Vaccine Adcomm Expertise, Pandemic Inspection Policies
Pink Sheet reporters and editors discuss the surprise US complete response letter for a new gene therapy and the specialists who may be added to the FDA’s coronavirus vaccine advisory committee, and also look at facility inspections during the pandemic.
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Pink Sheet Podcast: COVID Vaccine In Adolescents, CMS Drug Pricing Moves, Standard Care In Clinical Trials
Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.
Rolling reviews are now in progress at the European Medicines Agency for four COVID-19 vaccines and for four potential COVID-19 treatments.
Pink Sheet reporters and editors discuss the potential for the US and other governments to waive IP protections for COVID-19 vaccines, the FDA’s inspection backlog during the pandemic, and potential reimbursement changes for CAR-T therapies.