FDA Issues Social Media Draft Guidance
FDA’s Office of Prescription Drug Promotion (OPDP) announced today that it has issued draft guidance addressing when company use of interactive promotional media constitutes promotional labeling or advertising under the Food, Drug, and Cosmetic Act. In this long-awaited document, OPDP sets forth a proposal for company submission of such materials “at time of first use,” as required by 21 CFR 314.81 and 601.12. Links to the draft guidance and the related Federal Register Notice follow.
On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is ...06 October 2016
On 1 September 2016, the European Medicines Agency ("EMA") opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the...08 September 2016