FDA is holding to its existing stance on label requirements for manufacturers of OTC drugs and dietary supplements -- a full domestic mailing address or phone number, along with a clarifying statement, should be printed to facilitate the reporting of serious adverse events.
The OTC drug guidance is available here and the supplement guidance is found here. The documents, officially available Sept. 1, have been revised slightly since the agency last published its current thinking on the topic in December 2008. However, the changes reflect even more information that firms might consider adding to their labels, not verbiage they can omit.
Both guidances now state manufacturers can include an e-mail address or Web site URL on the product labels, in addition to the address or phone number already recommended. FDA also says labels could include a statement advising consumers to call a doctor about any serious AEs.
Continue reading "FDA Rolls Out Latest AER Label Guidance For OTCs, Supplements " »


