Opinion & analysis

FDA Announces More Actions On Drug-Coated Devices

Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.

FDA Announces More Actions On Drug-Coated Devices

FDA Asks Whether Supplement Industry Has Outgrown Regulatory Framework

FDA Ban On Flavoring Ingredients Should Prompt Removal From Fragrances – WVE

FDA Determined To Update Cosmetics Regs After Claire’s Refuses To Recall Asbestos-Tainted Makeup

FDA investigator insights: Device makers forget about the humans who use their products

FDA Plans Consumer Survey To Better Understand Cosmetics Allergy Prevalence

FDA’s Proposed Sunscreen Rule Could Bring SPFs Back Down To Earth, Deter SPF Fraud Suits

FDA’s Quality System Regulation Is Mapped To International Standard ISO 13485 – And Vice Versa – In New Report From AAMI

FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

Focus More On Patients, Less On Hospitals, Experts Tell Device Companies

Four Rules For Being A Consistent US FDA Reviewer From Peter Stein

From Device Centric To Disease Management: Ascensia Commits To Deeper Role In Diabetes

Game On For Akili’s Cognitive Control Tech

GE Healthcare’s New Value Proposition: The Strategic Language Of Software

Gene Therapy Investment At All Time High, Commercialization Challenges Noted

Gene Therapy’s Next Big Challenge: Manufacturing

Germany Begins The Year With Two Possible Rx-To-OTC Switches

Gilead Lures Roche Pharma CEO O’Day As CEO; Genentech’s CEO Will Replace Him

Global Biopharma R&D Productivity And Growth Rankings

Going ‘Beyond The Pill’ – Sanofi To Partner With Digital Health Start-ups In Europe

Going Generic: Big Brands Poised To Lose Marketing Exclusivity In The US In 2019

Goodbye To All That: EMA Leaves London After 24 years

Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

GSK And Pfizer Assemble Consumer Healthcare Leadership Team As JV Closes

GSK And Pfizer Start Consumer JV For Different Reasons, Aim For Similar Goals

GSK Woes Raise Big Pharma R&D Question

GSK’s Hal Barron On R&D Progress At TwoYear Mark

GSK’s Head Of Artificial Intelligence Unveils R&D Goals

Herbalife Shakes Up Executive Suite Due To CEO’s Earlier Statements On Expenses

House Committee Hearing Shows How Talc/Asbestos Concerns Could Be Impetus For Cosmetics Reform

How Roche Won The Bidding Battle For Spark

How To Pay For The New Wave Of Gene Therapies

How To Pay For The New Wave Of Gene Therapies

How To Read The UK’s New Medical Device Regulations: MHRA Explains The Main Points

Immuno-Oncology: Unicorns, China And The Perfect Storm

Immuno-Oncology: What To Watch At ASCO 2018

In Vivo’s Quick Guide To Gene Therapy

Infant Formula Production Stalls On Reckitt Benckiser’s Latest Stumble

Infographic – 2018 Pharma Pipeline Snapshot

Innovations In Market Access: The Will, But Not The Way?

Interventional Cardiology: Implantable Cardioverter Defibrillators

Interventional Neurology: Cerebral Aneurysm and Arteriovenous Malformation Systems

Into 2019: Risk, Uncertainty And A Return To Product Focus

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections