Pink Sheet Team
The policy and regulatory insights advantage for biopharma decision-makers around the globe.
Latest From Pink Sheet Team
Pink Sheet reporters and editors discuss the FDA’s approach to psychedelic drugs, whether postmarket clinical trial data from the Alzheimer’s drug Aduhelm will be published, and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee.
Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions, the US FTC and HHS investigation of drug shortages, and the potential for FDA-approved marijuana products.
Pink Sheet reporters and editors discuss the nearly wide open 2024 FDA advisory committee calendar, CMS’s impact on Florida’s drug importation plan, and the FDA’s many missed user fee goals in 2023.
We clean out your MLK Day inbox so you don’t have to.
Pink Sheet reporters and editors in the US and Europe consider the growth and impact of Project Orbis after a year in which two major regulators joined the program, but several countries did not keep up with the US approval pace.
Pink Sheet Podcast: Janet Woodcock Retiring, Accelerated Approval Reform, US FDA Meeting Recording Policy
Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches, the stance of the FDA’s oncology division on confirming benefit after an accelerated approval, and why formal meetings between the agency and sponsors cannot be recorded.