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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

Nine-Volume Title 21 CFR Set 2018

$585.00
The federal government has compiled the new 2018 CFR volumes.






View

Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. 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

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. 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

CDRH Reorganized: New Strategies for Devicemakers

$397.00
CDRH Reorganized lays out all of the moving pieces and lets you know what to expect, how to take advantage of new opportunities and how to influence the direction of the new system. And you’ll hear it from one of the people most qualified to interpret the changes, former CDRH Associate Director of Policy Paul Gadiock. View

Regenerative Medicine: Steps to Accelerate Development

$397.00
Regenerative Medicine outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify. The FDA granted RMAT designation to 12 organizations in 2017 — the first year of the program. Now is the time to get in the mix, work with the FDA to develop the program and improve your chance of being one of the next RMAT designees. View

Getting Real About Real World Evidence - Webinar Recording/Transcript

$287.00
Real world evidence — “RWE,” so-called — is making its way into your world. Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years, and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD, will walk you through the fast-moving RWE changes currently affecting the agency and business decisions alike. View

New Direct Marking Requirements for UDIs - Webinar Recording/Transcript

$287.00
The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language. View

European Medical Device Regulations (EU MDR) - Webinar Recording/Transcript

$287.00
Devicemakers face a market upheaval in the EU. A new set of rules — the Medical Device Regulation (MDR) — will soon supplant the longstanding Medical Device Directive, forever changing how you sell medical devices in EU nations. View

The CDRH Reorganization - Webinar Recording/Transcript

$287.00
Device regulation is about to change in ways large and small, as the CDRH moves toward a total reorganization. After it’s complete, the principal medical device overseer is expected to take a total product life-cycle (TPLC) approach, whereby postmarket realizations are fed back into premarket data requirements. View