On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more
The US District Court for the Middle District of Tennessee recently granted BioMimetic Therapeutics Inc.’s motion to dismiss the class action against it, and denied plaintiffs leave to amend their complaint. Shareholders...more
The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more
What you need to know:
The Martoma insider trading case is the latest in, and largest of, a string of actions brought by the Securities and Exchange Commission related to the alleged misuse of confidential clinical trial...more
Originally published in BNA’s Patent, Trademark & Copyright Journal on 09/28/2012.
When is a clinical trial an invalidating public use of an invention? Courts have struggled with this question — one particularly...more
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