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
Miracor Earns Breakthrough Designation for STEMI Heart Attack Treatment
STEMI heart attacks are considered the “classic” heart attacks.
FDA Approves Xenleta for Community-Acquired Bacteria Pneumonia
Patients treated with Xenleta had similar rates of clinical success as those treated with moxifloxacin.
FDA and EMA on the Same Page for Most Drug Approval Decisions, Analysis Shows
The EMA had a higher rate of first-cycle approvals. Read More
Clinical Trial Risk and Performance Management Summit
Discover the secrets to implementing a successful metrics program. Read More
Fitbit to Work With Singapore to Promote Public Health
The Fitbit devices will motivate participants to “adopt healthier habits and achieve better outcomes in the areas of physical activity, sleep, nutrition and emotional wellbeing,” the company said. 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
