Simplifying Global Compliance
Recommended Products
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
Lax Quality Observed at Device Facility in China
The company failed to investigate a customer complaint about a malfunctioning device.
Three Breast Cancer Drugs Pose Risks of Lung Inflammation, FDA Says
Possible symptoms include shortness of breath while resting or during low physical activity, the agency said.
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Using IT to Improve Data Integrity – Webinar Recording/Transcript
$287.00
Is IT a fully vested member of your data integrity team? The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View
Drug Regulation in China - Webinar Recording/Transcript
$287.00
Do you do business in China? With the fluidity — and uncertainty — of today’s regulatory environment, you must understand exactly what China has implemented, what is pending and what the near future holds. View
Understanding the Drug Supply Chain Security Act – Webinar Recording/Transcript
$287.00
As the Drug Supply Chain Security Act’s (DSCSA) key requirements continue to take effect, FDA has begun enforcement. If you must comply with DSCSA’s implementation requirements, this presentation can’t be missed. You’ll be updated on implementation processes to gain a clear understanding of the guidelines’ nuances and tactics to avoid problem areas. View
Regenerative Medicine and Stem Cell Regulation – Webinar Recording/Transcript
$287.00
If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells. View
Real World Evidence and Data – Webinar Recording/Transcript
$287.00
Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share critical factors you need to consider in using RWE and provide insight into the current and planned uses of RWE to support development and post-approval safety studies. View
Drug Pricing and Reimbursement – Webinar Recording/Transcript
$287.00
The drug pricing and reimbursement landscape is changing dramatically. Understanding the current policies — and proposed changes — and how to apply them to product development and commercialization plans will greatly impact the success of your products. View
Data Integrity – Webinar Recording/Transcript
$287.00
This presentation will explain high-level data integrity concepts, the definition and importance of data integrity, regulatory expectations for preventing data integrity issues, problem areas for data integrity and strategies for detecting potential data integrity issues in your operations. View
Organizing Data and Document Archives - Webinar Recording/Transcript
$487.00
Are your documents as organized as you think they are? Can you easily put your hands on the documents FDA investigators request? Or are you searching for that needle in a haystack? View
Extractables and Leachables: 101 - Webinar Recording/Transcript
$287.00
Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices. View
Perform Effective Investigations and CAPAs - Webinar Recording/Transcript
$287.00
The Corrective and Preventive Action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA violations are the most frequently observed Quality System subsystem cited by FDA regardless of the manufacturers shape or size. View
Secure and Accelerate Product Approvals - Webinar Recording/Transcript
$287.00
Join FDA legal experts Greg Levine, Esq. and Kelly Combs, Esq. as they clarify the advantages of qualifying for an expedited FDA approval program, what it takes to qualify and how to secure the benefits. View
