Simplifying Global Compliance
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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Bausch Hits Sandoz with Patent Suit over Xifaxan
Bausch asked the court to issue a permanent injunction against Sandoz’s generic until the patents expire.
Omega Medical Grabs FDA Clearance for AI Imaging System
The company claims that the device is the first of its kind in that it actually reduces radiation dose to patients and staff.
Nevada Fines Drugmakers $17 Million for Not Reporting Diabetes Drug Prices
The legislation imposed penalties of up to $5,000 for each day that companies fail to comply with the reporting deadlines. Read More
14th Annual FDA Inspections Summit
Over the course of two-and-a-half days, you’ll receive vital information from current and former FDA officials and industry experts aimed at your inspection readiness. Read More
Philips Earns FDA Approval for Low-Dose Drug-Coated Balloons
The approval broadens the options for physicians treating peripheral artery disease patients at high risk of recurrent narrowing of their arteries. Read More
483sOnline.com Your Personal Pre-inspection Toolkit
Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency explains the agency’s integrated approach and how you can make the most of the FDA’s quality priorities and inspection procedures.
Regulating Digital Health Tools: Understanding the FDA’s New Guidances
Regulating Digital Health Tools — based on a presentation by noted regulatory expert Bradley Merrill Thompson — combs through the guidances and sets out the rules devicemakers must follow.
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
This new edition of The 21st Century Take on Observational Studies presents new information on the encouraging results those pioneers have found. New to this edition are the results of a groundbreaking study from Tufts University’s Center for the Study of Drug Development.
The Solutions Center
