Submissions and Approvals

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Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Device Accessories: Understanding and Implementing FDA’s Guidance

$177.00
Device Accessories: Understanding and Implementing FDA’s Guidance explains the guidance document and gives you the tools needed to determine and document whether any of your products are a device accessory. View

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
Hack-Proofing Medical Devices will show you how to get — and keep — control of your devices’ networked operations. View

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language, culture) should be taken into account. View

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Medical Device Premarket Regulatory Pathways - Webinar CD/Transcript

$287.00
There’s a new pathway to medical device sales: The premarket approval process. It doesn’t involve the usual mechanisms — IDE, PMA, 510(k) — but rather, taking advantage of provisions tucked within the 21st Century Cures Act, and proposed Medical Device User Fee Amendments (MDUFA) IV goals. A business-friendly White House helps things along. View

Observational Research - Webinar CD/Transcript

$287.00
The 21st Century Cures Act promises to usher in a new era of drug development by dramatically lowering the cost of clinical trials while speeding the path to market. Noted researcher Jeff Trotter shows you how to take full advantage of the Cures Act and start reducing drug trial costs today. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
NEW for 2017 — You’ll get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






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Seven Steps to Successful Medical Device Reimbursement

$397.00
Order Seven Steps to Successful Medical Device Reimbursement for an overview of the regulatory and reimbursement processes and how they fit together. View