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
FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
Costa Rican OTC Drugmaker Hit for Testing, Stability Program
The company said it would employ a third-party testing laboratory, but it didn’t provide a description of the test it would conduct.
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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
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
FDA and EU Inspections – Webinar Recording/Transcript
$287.00
It’s been seven years since FDASIA was enacted and the path to globalized GMP inspections of drugmakers is complete at last. The Mutual Recognition Agreement (MRA) provides for inspection cooperation among the FDA and the 28 member nations of the EU. What happens now??? 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
Five-Volume Drugs/Biologics Title 21 CFR Set 2019
$300.00
The federal government has compiled the new 2019 CFR volumes. View
EU-Compliant Batch Release of Medicinal Products: How to Meet the Requirements of Annex 16 of the EU…
$135.00
The report covers critical elements of the product and process flow, strategies and tools a qualified person can use to manage supply chain, import, technical agreements and delegation. View
