Alicia M. Raines

Barnes & Thornburg LLP

Articles

Results 1 to 5 of 8


FDA issues draft guidance on cybersecurity for medical devices

USA - January 19 2016 The Food and Drug Administration (FDA) recently issued a draft guidance, “Postmarket Management of Cybersecurity in Medical Devices,” addressing…

Lynn C. Tyler, M.S.

FDA issues draft guidance on emerging signals for medical devices

USA - January 12 2016 The Food and Drug Administration (FDA) recently issued a draft guidance to describe its policy for notifying the public about medical device…

Lynn C. Tyler, M.S.

FDA issues draft guidance on voluntary labeling of GMO foods

USA - December 7 2015 The Food and Drug Administration (FDA) recently issued a draft guidance for manufacturers of human and animal food who want the labels of their…

Lynn C. Tyler, M.S.

FDA publishes final rule on foreign supplier verification program

USA - November 16 2015 The Food and Drug Administration (FDA) recently published its final rule on foreign supplier verification program (FSVP), which is being implemented…

Lynn C. Tyler, M.S.

Will FDA finally (and officially) define “natural?”

USA - November 16 2015 Less than two years ago, we reported here that the Food and Drug Administration (FDA) had issued a letter to three federal district court judges…

Lynn C. Tyler, M.S.