US FDA Actions On Rx Drug Promos Covered New Territory Last Year
Executive Summary
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.
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US FDA To Screen Rx Drug Launch Promos Prior To Initiating Review
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.
Azurity’s Xatmep Promotional Email To Healthcare Professionals Gets Dinged By US FDA
In second letter this year targeting email communications, OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’ comparable to the information on the drug’s effectiveness for the treatment of acute lymphoblastic leukemia that was in the body of the email.
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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