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Latest News | 6 May 2013

Regulatory Reconnaissance (6 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Viagra Online: Pfizer To Sell Popular Erectile Dysfunction Pill Directly To Patients On Its Read More...

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Latest News | 3 May 2013

Five in Focus – India Pushes for More Compulsory Licenses, EMA's Fight for Transparency and Reform

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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.If You Give a Mouse a Cookie… The Case Read More...

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Latest News | 3 May 2013

Citing Personal Reasons, Major Official Announces Departure from FDA

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A turbulent week for the staff of the US Food and Drug Administration (FDA) has affected yet another of the agency's top staff members, with Commissioner Margaret Hamburg announcing Friday that the Read More...

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Latest News | 3 May 2013

India Moves to Grant Three More Compulsory Licenses for Cancer Medications Based on Cost

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India's Union Health Ministry is pursuing three more compulsory licenses that would allow generic manufacturers in the country to compete with patent-protected medicines, including Roche's Herceptin Read More...

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Latest News | 3 May 2013

EMA Forming Four New Human Medicines Units within Agency

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If the European Medicines Agency (EMA) has seemed to be uncharacteristically silent in recent months, it's not just your imagination: It has been, toiling on a massive overhaul of the agency's Read More...

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Latest News | 3 May 2013

Meta Complaints: FDA Says Complaints to CDRH Lack Common Structure, New Standard Needed

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The US Food and Drug Administration (FDA) is preparing to overhaul the way it receives concerns and complaints about the way in which it regulates and approves medical devices, saying the complaint Read More...

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Latest News | 3 May 2013

French Regulator Back in Spotlight as Another Device is Alleged to Have Evaded Controls

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French regulator ANSM is once again finding itself in position it is all too familiar with: The spotlight. After enduring several scandals over the last two years, most notably those related to Read More...

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Latest News | 3 May 2013

Regulatory Reconnaissance (3 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA to Finally Study Whether Anti-Bacterial Soap is Safe (AP) FDA Panel Rejects Aveo's Read More...

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Latest News Regulatory Update | 2 May 2013

NICE Assuming New Duties, Will Assist NHS With Use of Innovative Medical Devices

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The UK’s cost containment agency, the National Institute for Health and Care Excellence (NICE), will soon begin to directly assist the National Health Service (NHS) with the use of innovative new Read More...

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Latest News | 2 May 2013

Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

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A US Senate proposal to overhaul the way in which compounded pharmaceutical products are regulated is being slammed by a prominent public advocacy group, Public Citizen, which claims that the proposed Read More...

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