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.
Inspections and Audits
RSS
ARTICLES
PRODUCTS
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
Clarity on Clinical Investigations – Webinar Recording/Transcript
$287.00
The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates. This presentation will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. View
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
$397.00
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. View
Corporate Compliance & Liability - Webinar Recording/Transcript
$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View
Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript
$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View
Real World Evidence and the NEST Program: An FDA Perspective - Webinar Recording/Transcript
$287.00
The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you. View
Top Tips for Dealing with the FDA - Webinar Recording/Transcript
$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View
Lean Management to Improve Quality & Compliance - Webinar CD/Transcript
$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View
ICH E6 R2 - Webinar Recording/Transcript
$287.00
The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions. View
Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript
$287.00
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. View
GCP Qualification Audits: Choosing Quality Contractors and Sites
$397.00
In GCP Qualification Audits, Ms. Sceppa lays out her approach to evaluating and selecting the best, most compliant and highest quality contractors to give your trial the best shot at success. View
Clinical Trials Adverse Event Reporting Guide, 2017 Edition
$397.00
You’ll find the answers to those questions and many more in the 2017 edition of Clinical Trials Adverse Event Reporting Guide. View
