Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Pink Sheet reporter and editors and HBW Insight editor discuss FDA reforms in the new user fee reauthorization bill, additional industry inducements to market OTC naloxone, and the impact of a Supreme Court’s potential overturning of Roe v. Wade on the agency.

Pink Sheet reporter and editor discuss next steps in the development of COVID-19 vaccines for young children, complaints about CMS’s coverage decision for Aduhelm, and the congressional investigation of McKinsey’s FDA conflicts of interest.

Pink Sheet reporter and editors discuss CDC advisors’ views on COVID-19 vaccine booster policy, new FDA guidance to promote clinical trial diversity, and what some FDA employees are finding when they return to the White Oak headquarters.

Pink Sheet

Pink Sheet reporter and editors discuss a grassroots campaign against coverage of a controversial Alzheimer’s treatment, the potential for drug pricing reform, and the pandemic effects on FDA hiring and retention.

Pink Sheet reporter and editors discuss new accelerated approval legislation, the changing FDA patient-focused drug development initiative, and the importance of access for COVID-19 treatments.

Pink Sheet reporters and editors discuss changes to the standard for some COVID-19 treatment emergency use authorizations, late-coming COVID-19 vaccines and their potential effect on the market, and an upcoming HHS biosimilar use and cost study.