US FDA’s COVID Master Protocol Guidance To Maintain Influence Post-Pandemic

Source : 'The Pink Sheet'

Guidance encouraging sponsors to use master protocols for coronavirus drug development also will influence US Food and Drug Administration policy on the clinical trial strategy going forward.

The FDA released a 

US FDA Refutes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

Source : 'The Pink Sheet'

For the second time in less than three months, the US Food and Drug Administration has taken the extraordinary step of publicly refuting a sponsor’s upbeat claims about the efficacy...

US FDA Cautions Against Blaming CRLs On Inspection Delays

Source : 'The Pink Sheet'

Manufacturing site deficiencies are not behind every recent complete response letter that mentions pandemic site inspection travel delays, the US Food and Drug Administration stresses in a 17 May

Biden’s Vaccine Donation Plan Emphasizes American Production, Not IP Waivers

Source : 'The Pink Sheet'

The Biden administration’s plan for creating a global supply of COVID vaccines appears to emphasize domestic production over IP waivers.

The controversial effort to break patents in order to speed...

Pink Sheet Podcast: Emergent On Capitol Hill, Second Cures Bill, US FDA’s Public Sponsor Rebuke

Source : 'The Pink Sheet'

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, and executive editors Bowman Cox and Nielsen Hobbs discuss the congressional grilling of Emergent BioSolutions, Inc.’s CEO and executive...