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The Opioid Crisis - Webinar Recording/Transcript

$287.00
The opioid crisis is out of control and drugmakers are in the crosshairs. The President is tweeting, the FDA has launched an Opioid Task Force, lawsuits are sprouting in courthouses across the land, and even local governments (Chicago is one) are investigating. View

Top Tips for Dealing with the FDA - Webinar Recording/Transcript

$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

Advertising & Promotion - Webinar Recording/Transcript

$287.00
Drug and device makers must advertise to survive, but the legal issues surrounding advertising and promotion are far from settled. FDA enforcement actions don’t seem to show a consistent pattern, leaving you to guess whether a warning letter lurks ahead and how to avoid it. View

Online Pharmacies — Impact on Regulatory & Quality - Webinar Recording/Transcript

$287.00
Websites selling junk drugs threaten the entire ethical drug business — manufacturers, suppliers, shippers, vendors, caregivers and patients too. It’s up to you to defend yourself. But how? View

Risk Evaluation and Mitigation Strategies (REMS) - Webinar Recording/Transcript

$287.00
Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb. 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