Reporters and editors from the Pink Sheet and sister publications covering the medical device and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.

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.