Just because a program or an app is running on an unregulated phone or tablet doesn’t mean that the app itself isn’t a medical device in the FDA's eyes. Like it or not, the FDA has made that clear. What’s not so clear? Where the agency draws the line between unregulated products and those the FDA must approve. Until now.

Buy now to immediately come up to speed on the new requirements of the proposed rule. This new report from FDAnews will take the anxiety out of the looming deadlines.

The European regulatory pathway for biosimilars has been in place for years. But if you think understanding the European model means you understand how biosimilars will be approved in the United States, you are making an expensive mistake. The FDA is crafting its own biosimilars regulations. The agency has made it clear that it intends to borrow from the European model in places, but the details of its own approval process have remained largely undefined – until now.

This six-disc package includes six modules, along with leader discussion guides, that illustrate for employees six of the most common mistakes that lead to ruined batches, recalls, or worse. Each 10- to 12-minute scenario shows how and why human errors occur, and reinforces the proper way to handle each situation.

This timely document takes you step-by-step through the most complex, challenging process validation compliance problems, filling in the gaps left in the available guidance.

Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected? Do your plans for dealing with drug shortages satisfy the new PDUFA requirements? How about your supplier quality agreements? Your facility registration? Your fast-track NDA? Your . . .

You’ve probably read the headline: Under MDUFA 2012, the FDA’s user fees will more than double. But the law does much more than that. It makes major changes to the way the agency regulates devicemakers – touching on everything from approvals to inspections.

This instructional guide and DVD creates a powerful, hour-long training event that shows employees the types of questions and tactics they’ll face during inspection, and gives them the confidence to respond correctly. Order Today.

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

This comprehensive, step-by-step guide is written by the foremost authorities in the pharmaceutical manufacturing field. It will walk you through an exhaustive, 45-topic analysis of managing contractors. Plus it’s loaded with tools and samples that will make your contract manufacturing headaches disappear.

Dubai ... or Denmark? India ... or Indonesia? Where will your next Rx market be? Choosing a new country or region to move into is a high-stakes decision. The right move could double your profits. The wrong one could put you out of business. You need information — lots and lots of it. And not just any information, but the highest-quality, most reliable information you can find. Look no further.

Dubai ... or Denmark? India ... or Indonesia? Where will your next medical device market be? Choosing a new country or region to move into is a high-stakes decision. The right move could double your profits. The wrong one could put you out of business. You need information — lots and lots of it. And not just any information, but the highest-quality, most reliable information you can find. Look no further.

Is your informed consent process effective and compliant with FDA and OHRP? If you hesitated for even a moment, kindly accept this invitation to preview — at no risk — the 2012 edition of  … Informed Consent for Clinical Trials: A Regulatory Reference Guide.

Produced by the British Pharmacopoeia Commission Secretariat, the British Pharmacopoeia 2013 is the leading collection of standards for UK medicinal products and pharmaceutical substances.

Only one guide aims specifically to help non-Chinese drug manufacturers get into compliance with China’s GMPs. By special arrangement, that guide is now available to FDAnews clients.