Pink Sheet Podcast: Cell Therapy Enforcement Discretion Ends, Inspection Normalcy, FDA Hiring Boom
Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.
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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.