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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.
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Develop World-Class SOPs that Minimize Human Error – Webinar Recording/Transcript
$287.00
Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View
Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/ Transcript
$287.00
What implications does the recent Instructions for Use (IFU) guidance have on your new drug applications and biologics license applications? Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it. View
Medical Product Off-Label Use and Marketing – Webinar Recording/Transcript
$287.00
Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. 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
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
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
Implementing a Risk-Based Cleaning and Disinfection Program - Webinar Recording/ Transcript
$287.00
Unless you are completely up to date with relevant cleaning and disinfection industry guidance documents, regulations and auditor findings… your current program may be in trouble. View
