Articles

Results 1 to 5 of 27
Most popular |Most recent


AdvaMed Updates Code of Ethics on Interactions with U.S. Health Care Professionals

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.

FDA Announces “Modernization” Reforms to Medical Device Review Process

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.

FDA revises approach to presentation of risk information in brief summary

USA - February 10 2015 On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for...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.

2014 year in review: OPDP warning and Untitled Letters

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.

CMS proposes changes to Physician Payments Sunshine Act implementing regulations

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.