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FDA issues Final Cybersecurity Guidance

USA - October 10 2014 On October 2, 2014, the U.S. Food and Drug Administration (FDA) took another critical step towards mitigating and managing cybersecurity threats by…

Brendan Carroll, Louis S. Dennig, IV, Kimberly Kiefer Peretti.

Ninth Circuit upholds Alameda County’s drug take-back ordinance

USA - October 6 2014 On September 30, 2014, the U.S. Court of Appeals for the Ninth Circuit upheld Alameda County’s Safe Drug Disposal Ordinance—a first-in-the-nation…

Maureen Gorsen, Elise N. Paeffgen.

cGMP requirements for outsourcing facilities…for now

USA - July 14 2014 Earlier this month, the U.S. Food and Drug Administration (FDA) issued an Interim Draft Guidance, "Current Good Manufacturing Practice - Interim…

Brendan Carroll, Guillermo E. Cuevas.

How to respond when FDA knocks: what happens when you say no?

USA - September 11 2013 Two months ago, the Food and Drug Administration (FDA) issued a Draft Guidance entitled "Circumstances that Constitute Delaying, Denying, Limiting…

Kelley Connolly Barnaby.

Cyber attacks on human health? FDA urges manufactures to tighten cybersecurity on medical devices

USA - June 20 2013 The U.S. Food and Drug Administration (FDA) is the latest government agency to respond to the growing concern over increasing cybersecurity threats…

Kimberly Kiefer Peretti.