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Latest News | 14 May 2013

Legislators Launch Investigation into Resignation of Prominent FDA Official

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Republican legislators on the House Energy and Commerce Committee announced on 13 May 2013 that they are opening an investigation into the unusual and unexpected departure of one of the US Food and Read More...


Latest News | 14 May 2013

Regulatory Reconnaissance (14 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US US Government Files Morning-After Pill Appeal (AP) (WSJ) (CBS) (The Hill) (SCOTUS Blog) Read More...


Latest News | 13 May 2013

FDA Says Reforms of Battery Equipment and Labeling Practices Needed

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As anyone who has ever lost power—be it because of a storm or a blown transformer—can attest, ours is a society that relies heavily on the use of electricity. Everything from our houses to our modes Read More...


Latest News | 13 May 2013

Ranbaxy Pleads Guilty to Felony Charges in Largest False Claims Case Ever

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The US Department of Justice (DOJ) has announced that Indian generic pharmaceutical manufacturer Ranbaxy has pleaded guilty to three felony charges, including lying to the US Food and Drug Read More...


Regulatory Update | 13 May 2013

Brazilian House Holds Hearing on Anvisa Regulatory Authority

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The Committee on Social Security and Family of Brazil’s House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil’s National Health Surveillance Agency Read More...


Latest News | 13 May 2013

Device Inspections, Deficiencies Skyrocket for Device Firms Since 2008

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The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device Read More...


Latest News | 13 May 2013

Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

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The US Food and Drug Administration (FDA) has announced that it plans to move forward with a proposed study on direct-to-consumer (DTC) advertising first announced in August 2012 regarding the use of Read More...


Latest News | 13 May 2013

In Shift, FDA Denies Endo Petition to Ban Generic Painkiller, Slamming Citizen Petition's Use of Data

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In a surprising move, the US Food and Drug Administration (FDA) on 10 May 2013 announced that it would permit generic competition to Endo Pharmaceuticals' generic pain pill Opana ER (oxymorphone Read More...


Latest News | 13 May 2013

Regulatory Reconnaissance (13 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Did FDA Make a Huge Blunder Approving Merck’s Liptruzet? (MPT) (Forbes) (Pharmalot) (Counter: Read More...


Latest News | 10 May 2013

Five in Focus | FDA Reaches out to Industry for 510(k)s and Generics, EMA Limits Phthalates

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Hello and welcome to a new  edition of Five in Focus, our Friday recap of the five most important, interesting, riveting or ground-breaking stories of the week.FDA Reaches out to Industry for Help as Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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