US FDA Aims For More Timely Reviews Of Rx Drug Launch Promotions
New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.
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Eton Pharmaceuticals gets untitled letter for promotion of its Alkindi Sprinkle hydrocortisone granules for treatment of pediatric adrenal insufficiency. The agency sent two letters last year objecting to sponsored links after a decade pause.
Office of Prescription Drug Promotion issued just six letters citing companies for improper drug promotion in 2020, including the placement of safety information in an email and making unfounded COVID-19 claims. New research projects focus on celebrity endorsements, medical conference materials.
Office of Prescription Drug Promotion is adding a five-day screening period to its review of core prescription drug launch materials to determine if they are actually core promotions with all necessary information. Companies can decide whether to resubmit materials deemed non-core or have FDA go forward with a non-core launch review.