Submissions and Approvals

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Medical Device Reimbursement Integration - Webinar Recording/Transcript

$287.00
Devicemakers often take a step approach to commercialization: you develop your medical device, get it approved, and then determine a reimbursement policy. That’s not best practice any more. 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

Global Regulation 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

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

$287.00
In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

$287.00
FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

China’s Medical Device Regulations - Webinar CD/Transcript

$287.00
China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers. The price is a familiar one: Compliance with China’s regulations. View

Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

$397.00
This report explains the criteria for each pathway, how to determine which one is right for your device and strategies for success. Fictional cases illustrate how the different pathways can be used. View

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

$177.00
Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows you where design control and risk management requirements overlap so you can serve both with one integrated effort. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

$287.00
Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View