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
European Commission Clears Up Devicemaker Vigilance Obligations
The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020.
Spanish Regulator Cites Drugmaker for Quality Fraud
The firm had stopped recording deviations and out-of-specification results for various drug products since January.
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Three-Volume Clinical Trials Title 21 CFR Set 2019
$210.00
The federal government has compiled the new 2019 CFR volumes. 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
Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript
$287.00
There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. 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
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
ClinicalTrials.gov: Mastering New Reporting Rules
$397.00
ClinicalTrials.gov: Mastering New Reporting Rules parses out the rules provisions, explaining who must report what — what information they must submit — what deadlines are — and what could happen if they miss the mark. View
