Pink Sheet Podcast: Vaccine Correlates, Simpler FDA Expedited Pathways, Real-World Evidence Guidance
Pink Sheet reporters and editors look at the search for COVID-19 vaccine correlates of protection, a potential effort to simplify the US FDA’s expedited approval pathways, and new guidance on the use of real-world evidence.
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Pink Sheet Podcast: Drug Pricing Reforms, Opioid Prescriber Education, China And FDA’s Project Orbis
Pink Sheet reporters and editors discuss new developments in US drug pricing reform, FDA considering mandatory opioid prescriber education again, and including China in the agency’s international parallel review initiative, Project Orbis.
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Pink Sheet reporters and editors discuss Bluebird Bio’s decision to pull its gene therapy business from Europe, Eli Lilly potentially pushing regulatory boundaries with its Olympic TV spots, and the CMS decision to scrap the Trump aministration’s most favored nation reimbursement rule.