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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From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.
“Sponsored searches” need to contain risk information, agency tells 14 firms in letters covering 48 products.
Two television commercials forBayer Healthcare's Yaz (drospirenone plus ethinylestradiol) broaden the oral contraceptive’s indication, overstate its efficacy and minimise risks, the US FDAhas said in a warning letter.