Clinical Trials

FDA Issues Proposed Rule Amending Regulations Regarding Acceptance of Data from Clinical Studies for Medical Devices

by King & Spalding on 3/12/2013

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

Life Sciences Company Obtains Dismissal of Shareholder Class Action

by William M. Regan | Katten Muchin Rosenman LLP on 1/23/2013

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

Chinese FDA Unveils Plan for Regulatory Reform

by Katherine Wang | Ropes & Gray LLP on 1/9/2013

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

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

by Antoinette F. Konski | Foley & Lardner LLP on 1/7/2013

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guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more

Recent Insider Trading Case Sparks Concerns Over Leaked Clinical Trial Results

by Choate Hall & Stewart LLP on 12/20/2012

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

Clinical Trials as Potentially Invalidating Public Uses: Current Issues and Future Questions Under the Leahy-Smith America Invents...

by Loeb & Loeb LLP on 10/15/2012

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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