FDA Sets The Record Straight On OTC AER Label Rules, Offers Grace Period
This article was originally published in The Tan Sheet
FDA will cut drug makers some slack on two recently enacted and potentially confusing legal label requirements for OTC products by postponing enforcement of both until Jan. 1, 2009
You may also be interested in...
A rule mandated by the FDA reauthorization Congress passed in 2007 that requires a toll-free number for reporting side effects on packaging for non-monograph OTC products and all Rx drugs went into effect Jan.1, but the agency likely will not enforce it until 2009
FDA's recommendation for complete addresses on OTC and dietary supplement product labels in order to comply with the adverse event reporting law exceeds not only Congress's intent, but also the requirements for all other products regulated by the agency, industry groups say
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.