FDA Presents Its Comprehensive Recommendations for DTC Ads

Direct-to-Consumer (DTC) advertising must be truthful and non-misleading while presenting the risk and benefits of a given product in a balanced easily understandable format. Although there is extensive marketing research on the best ways to communicate drug related information to consumers, a new FDA guidance provides a review of the available information with recommendations for … Read more

FDA Clarifies Rules for Compounding Pharmacies to Plug a Loophole

Compounding pharmacies registered as “Outsourcing Facilities” are allowed to mass produce compounded drugs in anticipation of prescriptions but are not allowed to sell their products on a wholesale basis. This distinction between what compounding pharmacies are allowed to do and what they are prohibited from doing is described in a new guidance document from the … Read more