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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

CDRH in Transition: Navigating the New Culture of Quality

$397.00
In CDRH in Transition: Navigating the New Culture of Quality he explains why compliance and quality don’t necessarily go hand-in-hand and how the center’s GMP inspections program intends to increasingly emphasize what a company is doing right over dinging them for what they’ve done wrong. 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

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

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

Advertising Medical Products - Webinar CD/Transcript

$287.00
Some drug and device TV ads earn fortunes. Others cost fortunes — in judgments, penalties and legal fees, hassles and wasted time, and lost reputation. Here’s how to tell one from the other. View

Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript

$287.00
Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. View