Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Reva Medical’s Fantom Encore Receives CE Mark
The expanded approval covers the Fantom Encore in 3.0 and 3.5 mm diameters.
FDA Seeks Comments on Technical Standards for Electronic Submissions
The agency wants to hear from stakeholders about “the use of technical specifications guidances and the data standards they contain.”
Commercial Operations
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Investigations Operations Manual 2018
$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View
Real-World Serialization in Life Sciences — 2018 - Webinar Recording/Transcript
$287.00
The FDA is now regulating serialization under the Drug Supply Chain Security Act (DSCSA). And the FDA is not alone: Regulators worldwide, from Brazil and Argentina to South Korea and Saudi Arabia, are adding scrutiny of their own. View
Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript
$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View
FDA’s New Concept of Operations for Drug Inspections & Evaluations - Webinar Recording/ Transcript
$287.00
ConOps is the acronym for a soon-to-take-place FDA restructuring that’s certain to affect drug inspections going forward. How will the agency’s new vertically integrated, programmatically aligned environment affect the new roles and responsibilities of CDER and ORA? View
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
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, and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD, will walk 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