USA - January 9 2019
The Updated Code Includes Several New Topics and Additional Guidelines on Existing Topics The Advanced Medical Technology Association (AdvaMed)...
Seth H. Lundy, Brian Bohnenkamp, Terrence B Burek, Gina Cavalier.
USA - December 3 2018
Last week FDA released two statements announcing plans and proposals aimed at modernizing the process for medical device review, particularly the...
Quynh T. Hoang, Kathryn B Armstrong (Kate), Elaine Tseng, Beverly H. Lorell, MD, Jessica Ringel.
USA - February 10 2015
On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for...
Anne Pierson Allen, Elaine Tseng, Christina M. Markus, Gillian Russell.
USA - January 30 2015
In 2014, the Center for Drug Evaluation and Research's (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters...
Elaine Tseng, Christina M. Markus, Gillian Russell.
USA - July 10 2014
On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) released four proposed changes for comment to the implementing regulations for...
Seth H. Lundy, Brian Bohnenkamp, Terrence B Burek, Gina Cavalier.