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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

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

Medical Product Advertising & Promotion - Webinar Recording/Transcript

$287.00
Social media is a two-edged sword — a boon for getting your message out, a magnet for warning letters should you run afoul of the FDA. 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

Advertising Drugs and Devices: Keys to FDA and FTC Compliance

$177.00
Advertising Drugs and Devices: Keys to FDA and FTC Compliance, a hands-on guide, lays out the advertising landscape as the government sees it — regulations, requirements, expectations — and shows you the right road to take to compliance. View

The U.S. Opioid Crisis - Webinar Recording/Transcript

$287.00
The opioid crisis is the stuff of daily headlines. But behind the headlines lurk serious implications for drugmakers, healthcare providers and other regulated firms. View

Must-Know Contracting for Non-Lawyers - Webinar Recording/Transcript

$287.00
When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Young Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. 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

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