Eleven months ago, an FDA warning letter was a rare event. Enforcement letters had fallen from more than 130 a year in the late 1990s to just five in all of 2024. Then came last September, when the FDA’s Office of Prescription Drug Promotion (OPDP) sent more than 60 warning and untitled letters in a […]
Image: Eric Muller, Chief Executive Officer of Lucid Group Rick Sannem, outgoing CEO, transitions to Strategic Advisor to the Board LONDON & PHILADELPHIA, 19 August 2026 – Lucid Group, a leader in healthcare communications and commercialisation, today announced that Eric Muller has joined the agency as Chief Executive Officer. He will succeed CEO, and […]
The FDA has launched a salvo at branded television advertising by trying to officially change the adequate provision rule, which allows for alternative means of risk disclosure. Eliminating adequate provision would force the full disclosure of all risks and side effects included in the approved label. This would effectively eliminate the ability to run […]
Getting a patient diagnosed and prescribed is hard. Keeping them on therapy long enough to see real benefit? That’s often even harder — and the stakes couldn’t be higher. Most medications don’t deliver their full effect after a single fill. Antidepressants require weeks of consistent use before therapeutic stabilization sets in. Biologics for chronic skin […]