Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Reva Medical’s Fantom Encore Receives CE Mark
The expanded approval covers the Fantom Encore in 3.0 and 3.5 mm diameters.
FDA Seeks Comments on Technical Standards for Electronic Submissions
The agency wants to hear from stakeholders about “the use of technical specifications guidances and the data standards they contain.”
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FDA’s NEST Program and Real World Evidence - Webinar Recording/Transcript
$287.00
The FDA is working on simplifying the evaluation of new medical devices via Real World Evidence (RWE). The FDA initiative is known as NEST (National Evaluation System for Health Technology) … and it could benefit you. View
Three-Volume Clinical Trials Title 21 CFR Set 2018
$210.00
The federal government has compiled the new 2018 CFR volumes. View
Inside FDA’s Oncology Center of Excellence - Webinar Recording/Transcript
$287.00
Cancer therapies have a new friend at the FDA. The year-old Oncology Center of Excellence is tasked with expediting development of oncology and hematology medical products — drugs, biologics and devices — and supporting an integrated approach to clinical evaluation of cancer treatments. 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
The FDA Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript
$287.00
In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View
Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript
$287.00
In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View