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
FDA Approves Contact Lens for Myopia in Children
The lens focus light on the back of the eye, which is believed to reduce progression of the condition.
HHS Hits Gilead With Patent Infringement Suit Over PrEP Drugs
Truvada was approved in 2012 for use as a PreP regimen, and Descovy was approved in October 2019 as a PrEP regimen.
CDER Reorganization Enters New Phase, Naming Three New Offices
Some INDs, NDAs and BLAs may be affected during the implementation process. 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
Genedrive Gets FDA Clearance for Baby Deafness Diagnostic
The diagnostic test can screen infants for the deafness-causing genetic mutation in under 30 minutes. Read More
International Devices and Diagnostics Monitor
Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. 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
