Category: FDA

FDA “Bad Ads” – Now for CME Credit…

On October 25, 2013, the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) updated its “Bad Ad Program” website to add an accredited CME module and case studies, designed to “educate healthcare professionals and students about the role they can play in helping the FDA ensure that […]

FDA Seeking Comments on DTC Aimed at Adolescents

On October 30, 2013, the U.S. Food and Drug Administration (FDA) announced that it is seeking public comments on research titled: “Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents.”  The pre-publication notice is available here, and final publication is expected in the October 31, 2013 Federal Register.  According to the […]

Regulator Panel at FDLI’s Advertising & Promotion Conference

The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

FDA Continues Enforcement Against Internet Marketing of Unapproved and Misbranded Drugs

EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites.  The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten […]