Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.

Careful identification and vetting of spokespersons, training on FDA regulations, and development of content that conveys the typical patient experience are keys to successful and compliant influencer campaigns, advertising, legal and regulatory experts told a recent DIA conference.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

PureTech’s LYT-100 has failed to show benefit over placebo in long COVID, and raised doubts about how treatable the condition is – in contrast to the drug’s other potential use in idiopathic pulmonary fibrosis.