Cathy L. Burgess
Alston & Bird LLP
Articles
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…
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USA - July 14 2014 Earlier this month, the U.S. Food and Drug Administration (FDA) issued an Interim Draft Guidance, "Current Good Manufacturing Practice - Interim…
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USA - September 11 2013 Two months ago, the Food and Drug Administration (FDA) issued a Draft Guidance entitled "Circumstances that Constitute Delaying, Denying, Limiting…
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…
