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Regulatory Affairs

 In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.
Posted: August 17, 2018, 6:19 pm
As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September.
Posted: August 17, 2018, 6:03 pm

This article discusses regulatory issues related to Drug Device Combinations (DDCs) and speculates on how they will continue to be regulated as medicines under the new EU Medical Device Regulations. 

Posted: August 17, 2018, 4:00 pm
Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions.
Posted: August 17, 2018, 2:57 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: August 17, 2018, 2:33 pm



Hired someone new and exciting? Promoting a rising star? Finally solved that hard-to-fill spot?
Author: Ed Silverman
Posted: August 17, 2018, 3:35 pm
Here are four ways in which NYU's decision to offer free tuition to its medical school students will have ripple effects across the U.S. health care system.
Author: Eli Cahan
Posted: August 17, 2018, 3:26 pm
Purdue Pharma has hired the Davis Polk & Wardwell law firm for financial restructuring advice.
Author: Ed Silverman
Posted: August 17, 2018, 1:26 pm
“Congress cannot appropriately fix the problem of high drug prices unless we have correct information about what is causing them and who is responsible.”
Author: Ed Silverman
Posted: August 17, 2018, 9:45 am
Hospitals across the nation and beyond need to rise to the challenge and provide foreign patients with the level of support they deserve.
Author: Eric Alberts and John Corfield
Posted: August 17, 2018, 8:40 am

Human Resources

According to Unum, an employee benefits provider, making auto-enrollment the default option could ease some of the anxieties open enrollment incites.

Posted: August 17, 2018, 2:07 pm

It's a diversity issue, says HR Dive’s senior editor, Kate Tornone. If you want women in leadership and want to eliminate your gender pay gap, it needs to be OK for your male employees to take time off.

Posted: August 17, 2018, 2:01 pm

While compliance efforts often focus on avoiding litigation, there's so much more at stake — and employers are hoping automation and other tech can help.

Posted: August 17, 2018, 1:58 pm

More than half (58%) of respondents to a survey by The Predictive Index said that a bad boss' worse trait is not setting clear goals.

Posted: August 17, 2018, 1:52 pm

In workplaces where inappropriate behavior continues to illicit poor excuses for discipline, HR leaders may need to step in to reform their departments.

Posted: August 17, 2018, 1:51 pm