Pink Sheet Team
The policy and regulatory insights advantage for biopharma decision-makers around the globe.
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Latest From Pink Sheet Team
Supplemental Filings: FDA Expands In-Person Meeting Eligibility Again; Marks Suggests Sponsors Invite Foreign Regulators To FDA Meetings
More formal meetings are available for in-person sessions with the US FDA. Also, CBER Director Peter Marks offers advice for conducting meetings, from how to do hybrid right to how to include patient groups and foreign regulators.
Pink Sheet Podcast: Alzheimer’s Drugs, US FDA’s New Patient Info Leaflet, COVID-19 Vaccine Harmonization
Pink Sheet reporters and editors discuss CMS’s latest coverage announcement for Alzheimer’s drugs and the VA’s approach to the issue, the FDA’s new one-page patient medication information document, international convergence on COVID-19 vaccine strain selection and Novavax’s place in the vaccine toolbox going forward.
Pink Sheet Podcast: Big Pharma’s US FDA Scorecard, Sarepta’s DMD Gene Therapy Delay, US FDA Adcomm Reforms
Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications, the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy, and a plan to add more temporary members to agency advisory committees … as well as a little bit of “The Simpsons.”
Supplemental Filings: Califf Discusses Revolving Door; Poll Examines Public Trust In FDA Approvals
Commissioner expresses concern about agency lawyers leaving and then representing US FDA’s opponents in court. Also, as lawsuits about abortion pill continue, KFF finds the public trusts FDA more than the judiciary on determining products’ safety and effectiveness.
Supplemental Filings: FDA Can't 'Plug' All Shortage Holes, New Jobs For Billy Dunn, Lisa Parks & Heidi Rebello
From infant formula to drugs, Califf can't get away from shortage work. Plus, the revolving door brings new jobs for some top pharma folks.
Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More
Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.