Research and Development

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510(k) Change Analysis - Webinar Recording/Transcript

$287.00
On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View

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

Expanded Access at a Crossroads - Webinar Recording/Transcript

$287.00
Expanded Access is the hottest topic in new-drug development, and now the FDA appears ready to loosen the reins. View

Making Sense of IVD Regulation - Webinar Recording/Transcript

$287.00
Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result. View

Process Capability Indices for Medical Device Manufacturers - Webinar Recording/Transcript

$287.00
In device manufacture, QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. Particularly tricky: calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and you’re well on your way to cleaner inspections. 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

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

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

$397.00
Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy explores the draft guidances and other FDA activity on the subject of promotional communication — explaining what companies must do to stay on the right side of the agency’s new policies and how to take advantage of the opportunities they present. View