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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with FDA’s recent release of its Draft Guidance on Best Practices in Developing Proprietary Names for Drugs, drives the authors to ask: When it comes to innovative drug products, what’s in a name?
Australia’s Therapeutic Goods Administration (TGA) has announced (11 September) an internal reorganization as part of broader structural changes within the Department of Health following the Finance Ministry’s call for a "smaller and more rational" government.
The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.