Sunshine Act

With the “Physician Payment Sunshine Act” data collection requirement going into effect on August 1st, we’re continuing to monitor and analyze the changes the Final Rule has on the operations of entities in the life sciences industry and the significant implications of the changes for research.  Our group has written many articles on the Sunshine Act, clarifying its requirements, and offering practical advice for compliance.  Below you will find all articles we’ve written on the subject matter, to date.  Stay tuned for more.






From the Blog

“Dear Doctor” Letters: FDA Removes Behavior Tracking Recommendations from Proposed Guidance

On July 9, 2013, the United States Food and Drug Administration (FDA) announced a modification of certain recommendations contained in the November 2010 draft...

Navigating the Isolated DNA Patent Eligibility Jungle
Introduction

For over 150 years the Supreme Court has provided three categories of exceptions to patent eligibility under 35 U.S.C §101:  abstract ideas, laws of...

Drug Import Regulation: On the Brink of Historic Change

On Friday, July 12, 2013, the Food and Drug Administration (FDA) hosted a public meeting to discuss the implementation of the drug supply chain...