Tag: FDA Enforcement

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

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 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 […]