Insights on Drugs & Biologics

77 total results. Page 4 of 4.

Alerts
A Sample of What’s to Come: FDA Issues a New Guidance on the Required Submission of Information on Samples of Drug Products
Brian P. Waldman, Wayne H. Matelski

On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States. The new Guidance is entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.”

Alerts
FAQs on FDA’s New Draft Social Media Guidance for Prescription Drugs and Biologics
Brian P. Waldman, Wayne H. Matelski

On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”