Opinion & analysis

Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

Names have not been made public, but two frontrunners have been chosen as contenders for notified bodies under the European Union’s new Medical Device Regulation. Find out who the frontrunners could be, and how timing is playing a critical role in this crucial announcement.

Two EU Notified Body Frontrunners In Race For Designation Under New Regulations

Two First MDR Certificates Issued – Are Floodgates Open For Mass Certifications?

Two More EU Notified Bodies But Not On Nando Yet

UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

Unilever Seeks End To Litigation Over St. Ives Scrub, Plaintiffs’ ‘Fake Medical Condition’

US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

US FDA Looks To Standardize Premarketing Safety Assessments

US FDA May Largely Avoid House Democrats’ Investigation Agenda

US FDA’s Gottlieb Shuts The Door On Exclusivity For ‘Transition’ Biologics

US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

US FDA’s Shutdown Offers One Possible Winner

US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

Vanda Warning Letter From US FDA Leaves Firm “Puzzled”

Verseon Playing The Long Game To Level Up Drug Discovery

Virtual AI Nurses And The Future Of Chronic Disease Management

Want To Add A Drug Coating To Your Device? Check FDA’s New Guide

Wearables are Transforming R&D and Care Delivery

What Do Cosmetics Reform Campaigners Dream Of At Night? Rep. Schakowsky Just Reintroduced It

What Does 2019 Hold For Biopharma?

What Does It Take To Launch And Lead An Oncology Biotech Today?

What GSK’s Immunology Chief Did Next

What Should You Be Earning? Salary Benchmarks And Hiring Trends In Regulatory Affairs

What’s Under The Iceberg: GE Healthcare’s Deep Dive Look At Future Of Gene Therapy

Why Deals Fail: The Reasons May Be Clinical, Economic Or Strategic

You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments