Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) released its much-anticipate report to Congress on when a modification to a 510(k) medical device triggers the need for submission of a new 510(k). In July 2011, CDRH issued draft guidance that significantly overhauled document K97-1, …
D.C. Court of Appeals Upholds FDA Jurisdiction in Regenerative Sciences
February 10, 2014 Leave a Comment
Last week, the D.C. Court of Appeals upheld the FDA’s District Court victory in United States v. Regenerative Sciences, LLC, No. 12-5254. The District Court in Regenerative Sciences held that the FDA had jurisdiction over stems cells extracted from a patient, processed, and then injected in the same patient …
Supreme Court Denies Cert in Harkonen
December 19, 2013 Leave a Comment
The Supreme Court denied certiorari this week in Harkonen v. United States. Harkonen was convicted of wire fraud related to statements he made in a press release about an FDA-regulated clinical study. In his petition for certiorari, Harkonen raised basic First Amendment issues and an interesting and novel …
President Obama Signs the Drug Quality and Security Act
December 4, 2013 Leave a Comment
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law. Title I of the Act establishes national standards for compounding pharmacies designed to fill regulatory gaps that contributed to the 2012 meningitis outbreak. Title II—arguably the more important of the two …
Center for Medicare & Medicaid Innovation
May 16, 2013 Leave a Comment
Healthcare providers and payers may be salivating today with the news that the Center for Medicare & Medicaid Innovation (CMMI) – created under the Affordable Care Act and funded at $10 billion – announced a new $1 billion funding opportunity for innovations with promise to improve healthcare outcomes and …
FDA Explains Decision Not to Seek Rehearing in Caronia
January 23, 2013 Leave a Comment
Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …