As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
10/1/2014 - 11/30/2014
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The Hatch-Waxman Amendments are 30 years’ old this month and
introduced generics as we know them. Its milestone anniversary, combined
with FDA’s recent release of its Draft Guidance on Best Practices in Developing Proprietary Names for Drugs, drives the authors to ask: When it comes to innovative drug products, what’s in a name?
The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
An overview of FDA’s 2009 enforcement actions for violations related to paid search engine marketing (SEM) and lessons learned combined with subsequent developments for creating a framework for using SEM compliantly, including areas where FDA guidance is still unavailable or unclear.