Pink Sheet Podcast: Makena Hearing Take-Aways, Industry’s Accelerated Approval Failings, US FDA Claims Enforcement
Executive Summary
Pink Sheet reporters and editors discuss lessons from the public hearing on the proposed withdrawal of the preterm birth prevention drug Makena, FDA Commissioner Califf’s opinion that industry is not meeting expectations with accelerated approval confirmatory studies, and agency efforts to clarify that staff is paying attention to comparative claims in product ads.
You may also be interested in...
Pink Sheet Podcast: RSV Vaccine Questions, Lilly Lowers Insulin Cost, Orphan Drug Act Changes
Pink Sheet reporters and editors discuss US FDA advisory committee members’ concerns about two proposed RSV vaccines, Lilly’s plan to lower the cost of its insulin products, proposed changes to the Orphan Drug Act, and the departure of the influential leader of the FDA’s neuroscience office.
Publisher’s Spotlight: Citeline Awards 2023 Finalists Announced
We are delighted to announce the shortlist for the seventh annual Citeline Awards, recognizing clinical and research excellence across the biopharmaceutical, CRO and diagnostics industries.
Pink Sheet Podcast: Limiting Medicare Price Negotiation, More US FDA Adcomm And COVID-19 Vaccine Concerns
Pink Sheet reporters and editors discuss the impact of PhRMA’s new push to limit Medicare price negotiations, Congress’ interest in FDA advisory committee reforms, and concerns about the COVID-19 vaccine strain selection process.