Regulatory Affairs


FDA Proposes Opioid Packaging Reductions

The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More

Stakeholders Prefer TGA’s Modified Approach to Naming Biologics

An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to adopt suffixes may offer little benefit for pharmacovigilance. Read More


Getting Real About Real World Evidence - Webinar Recording/Transcript

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

FDA Inspection Intelligence - Webinar Recording/Transcript

Drug and biologics makers are facing increased scrutiny of data integrity as an energized FDA deploys new tools to empower inspectors and concerns rise over Forms 483 and warning letters. View

Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

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

Risk Management in Clinical Trials: The New ICH E6 Focus

In Risk Management in Clinical Trials Dr. Leister explains the significance of the new focus on risk management and the benefits it can reap. View

Guide to FDA Drug Safety Regulation, 2018 Edition

The FDA has upped its drug safety game since the last edition of Guide to FDA Drug Safety Regulation, adding more than 30 new, revised and finalized pharmacovigilance guidances, 12 of them in 2015-2017 alone. View

Regenerative Medicine - Webinar Recording/Transcript

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

“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

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

Compliance Confidence: Strategies for a Successful Regulatory Inspection

Order the Compliance Confidence DVD learning set and learn strategies on how to prepare for, manage and respond to the inspection process. View

Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript

There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View

How to Build A World-Class Audit Team - Webinar Recording/Transcript

Meet Susan Schniepp. She’ll show you how to avoid warning letters ... maybe forever. The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud. View

Generic Drug Development: A Guide to FDA Regulation

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