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.

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.

New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.