The Food and Drug Administration (FDA) recently issued a draft guidance titled "Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States." The draft guidance arises out of s. 1123 of the FDA Safety and Innovation Act (FDASIA), enacted in July 2012. This section…

What Happened? Another federal district court ruled that the United States Supreme Court's ruling in Buckman v. Plaintiffs' Legal Committee is precedential in finding preemption of failure to warn claims based on withholding information or misrepresenting information to FDA. What Does It Mean? The…

The Food and Drug Administration (FDA) issued its interim final rule requiring that importers or purchasers submit notice to FDA prior to importing or offering for import any food into the United States. The rule was published in the Federal Register on Oct. 10, 2003. A detailed explanation of the…

Silver Spring, MD -- The following information was released by the U.S. Food and Drug Administration: Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the…

On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck's Lab, Inc. denied a request by the U.S. Food and Drug Administration ("FDA") for an injunction and summary judgment against a compounding pharmacy, Franck's, and firmly rejected the FDA's…