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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, walks you through the fast-moving RWE changes currently affecting the agency and business decisions alike. View

Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

$287.00
The 21st Century Cures Act has ushered in a new era of business friendliness. Helped along by a pro-business White House and Congress, the FDA wants to help get your new drugs to market. View

Guide to FDA Drug Safety Regulation, 2018 Edition

$397.00
The FDA has upped its drug safety game since the last edition of Guide to FDA Drug Safety Regulation, adding more than 30 new, revised and finalized pharmacovigilance guidances, 12 of them in 2015-2017 alone. View

Regenerative Medicine - Webinar Recording/Transcript

$287.00
The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies. But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way? 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

Generic Drug Development: A Guide to FDA Regulation

$397.00
Generic Drug Development contains all of the FDA’s generics-related guidances, plus internal agency policies on reviewing applications, instructions for challenging patents and even lists of branded drugs with expired patents and no generic competition. View

European Drug Assessment Policy for Biological Medicine - Webinar Recording/ Transcript

$287.00
Biologics and chemical-based medicines are fundamentally different, nowhere so much as under CMC policy changes set forth recently by the EU. But savvy biologics makers are already seeing a double-barreled opportunity in the EU’s action — avoiding costly compliance errors while boosting sales in the bargain. View

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

$397.00
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. View

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

$397.00
In Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it. 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