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Archive for the ‘Food and Drug Administration’ Category

On August 14, 2014, the U.S. Food and Drug Administration (FDA) issued Draft Guidelines on the direct de novo classification process, a means of accelerating the approval of new types of medical devices posing only low to moderate health risks.[1]  The FDA created de novo classification in 1997, but after the process failed to achieve its purpose of expediting approval, the FDA introduced an alternative de novo process called “direct” de novo.

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Posted On Jun - 16 - 2016 Add Comments READ FULL POST

Flash Digest: News in Brief

By Gia Velasquez – Edited by Olga Slobodyanyuk

The Federal Aviation Association Implements a Mandatory Registration Process for Drones

The FDA Expedites the Review Process for Generic Pharmaceutical Drugs

Senate Rejects GMO Labeling Bill

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Posted On Mar - 22 - 2016 Comments Off READ FULL POST

Flash Digest: News in Brief

By Mila Owen – Edited by Olga Slobodyanyuk

Senate CISA Debates End

The FDA CDRH released its Regulatory Science Priorities for 2016

Germany requires all Internet companies to make metadata available to its law enforcement agencies

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Posted On Nov - 4 - 2015 Comments Off READ FULL POST

Illinois District Court Opinion Shows Uncertainty of the Economics of ANDA litigation

By Yaping Zhang – Edited by Mengyi Wang

The Northern District of Illinois just laid down a Hatch-Waxman opinion, holding that the Mylan Pharmaceuticals Inc. infringed the patent No. 727 Patent held by Medicines Company. Patently-O published a study that demonstrates ANDA Paragraph (iv) cases have increasingly settled, reducing consumer surplus. The case suggests that there are potentially more complicated calculus and players embedded in ANDA litigations than originally thought.

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Posted On Nov - 10 - 2014 Comments Off READ FULL POST

Flash Digest: News In Brief
By James Grace

Hershey’s Opposes Mars’ Attempt to Register a Snickers’ Cross-Section as a Design Mark

Medtronic v. Boston Scientific – Oral Argument

Proposed Tweak to Law Would Pull Shield From Generic-Drug Makers

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Posted On Nov - 10 - 2013 Comments Off READ FULL POST
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