Regulatory Affairs


EMA Calls for Details, Narratives in Marketing Applications

Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More


Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

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

Advertising Medical Products - Webinar CD/Transcript

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

Implementing Elemental Impurities Testing - Webinar CD/Transcript

A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs. View

Biosimilars Regulation: The Importance of Interchangeability - Webinar CD/Transcript

The biosimilars industry is at a crossroads known as interchangeability. Drug and biologics firms that are first to master this key concept stand to reap the greatest rewards. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

Navigating New Terrain in Advertising and Promotion of Medical Products - Webinar CD/Transcript

The rules on drug and device marketing are changing. In the absence of settled policy, your safe harbor lies in following the terms of three draft FDA guidances. View

ICH Stability Requirements - Webinar CD/Transcript

Compliance with ICH stability requirements is a necessary step in getting your new drugs approved. Yet drugmakers routinely give it short shrift — to their sorrow. View

FDA’s Big 5 Challenges - Webinar CD/Transcript

The FDA likely will break new ground this year, posing extraordinary regulatory challenges to Rx, food and tobacco interests. Botox. Cannabis. Opioids. Tobacco intended use. State right-to-try initiatives. How will the FDA tackle these hot potatoes? View

Spreadsheet Validation 2017 - Webinar CD/Transcript

What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

GMP Inspection Preparation Checklist: A Tool for Internal Auditing includes more than 650 items organized in three sections covering all aspects of quality manufacturing. View