Regulatory Affairs

AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

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

Microbiome-Based Products: FDA Delves Into the Unregulated

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

Drug Delivery Combinations and new EU Medical Device Regulations

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

FDA and NCI Draft Pediatric Molecular Target List

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

Recon: Novo Nordisk Acquires Diabetes Firm Ziylo for $800M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Posted: August 17, 2018, 2:33 pm

Biotechnology

Updated: Iovance Continues Path in Developing TIL Treatments for Solid Tumors

August 17 Research Roundup: Glaucoma, Lung Cancer, Migraines and Spaghetti

Bay State is Home to Four Biotech Unicorns

ITUS Corporation to Present at Next Generation Dx Summit

CEL-SCI Announces That the NYSE American Approves Plan

Pharmaceuticals

STAT Plus: Up and down the ladder: The latest comings and goings

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

Opinion: NYU medical school students are getting free tuition. But everyone will reap benefits

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

STAT Plus: Pharmalittle: Trump wants opioid makers to cut production quotas; Purdue looks to restructure

Purdue Pharma has hired the Davis Polk & Wardwell law firm for financial restructuring advice.

Author: Ed Silverman

Posted: August 17, 2018, 1:26 pm

STAT Plus: Senators challenge Azar over his comments about PBMs and price cuts

“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

Opinion: The Pulse nightclub tragedy changed how one hospital treats foreign patients

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

Employees spend 30 minutes or less reading open enrollment materials

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

Want women in leadership? Give dads paid leave

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

Employers look to overhaul compliance functions with tech

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

Bad bosses play favorites, bad mouth their colleagues

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

Survey: 70% of tech employees don't trust HR

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