The U.S. Food and Drug Administration issues draft guidance titled “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)” to address the proper collection, storage and manufacture of animal-derived materials that could pose a risk of infectious disease transmission. Comments are requested by April 23, 2014.
The U.S. Food and Drug Administration (FDA) announces that its collection of information titled “Investigational New Drug Safety Reporting Require- ments for Human Drugs and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” has been approved by the Office of Management and Budget. The approval expires December 31, 2016.
The U.S. Food and Drug Administration (FDA) issues draft guidance titled “Guidance for Industry Fulfilling Regulatory Requirements for Postmar- keting Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” Intended to address how drug manufacturers can properly promote their products on social media such as “blogs, microblogs, social networking sites, online communities, and live podcasts,” the document discusses, among other things, when manu- facturers are responsible for the content of promotional material and how such communications should be provided to regulators for review. It also covers the circumstances under which a manufacturer is respon- sible for promotional content and is thus required to submit that material to FDA. Comments are requested by April 14, 2014.