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Latest News | 24 May 2013

Five out of Focus | India's Weird Week, Hackers Target Clinical Data, EU Device Proposals Advance

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Hello and welcome to a new  edition of Five out of Focus, our Friday recap of the five most important, interesting, riveting or ground-breaking stories of the week covered by a publication other than Read More...


Latest News | 24 May 2013

Five in Focus | EMA's Digital Switch, Congress Deliberates FDA, Patients Take Center Stage

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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.EMA to Phase out Non-Electronic Read More...


Latest News | 24 May 2013

India Finalizes Guideline Meant to Bring Country into Compliance with New EU API Rules

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India has issued new guidelines meant to bring the country—and its significant generic pharmaceutical industry—into compliance with new EU rules requiring that active pharmaceutical ingredient exports Read More...


Latest News | 24 May 2013

FDA Publishes Wish List of Regulatory Science Projects, Plans to Spend up to $50 Million

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US regulators have published a new agency contracting announcement regarding advanced research and development for regulatory science, saying it wants to "advance the state of the art and achieve Read More...


Latest News | 24 May 2013

FDA Announces Adoption of ICH Guideline on Pharmaceutical Powders

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The US Food and Drug Administration (FDA) has released a new guidance document bringing the agency into alignment with the International Conference on Harmonisation's (ICH) standard on the approval of Read More...


Latest News | 24 May 2013

Regulatory Reconnaissance (24 May 2013)

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Focus will be observing Memorial Day in the US on 27 May and will resume normal operations on 28 May.In Read More...


Latest News | 23 May 2013

Untitled to Letter to Shionogi Threatens to Revoke Marketing Clearance for Painkiller

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The US Food and Drug Administration (FDA) has sent a rare Untitled Letter to pharmaceutical manufacturer Shionogi for the alleged failure of the company to comply with the terms of the mandatory Read More...


Latest News | 23 May 2013

Trend in Warning Letters Points to Crackdown on Contract Manufacturing Using Logic of Park Doctrine

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When the US Food and Drug Administration (FDA) wants to make a point, it often does so through a series of similar-sounding Warning Letters. Earlier this year, for example, the agency sent eight Read More...


Latest News | 23 May 2013

EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

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EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication Read More...


Regulatory Update | 23 May 2013

EU Health Cost Containment Panel Members Nominated

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The European Commission has released the names of the first members to sit on the panel of experts it established in 2012 to provide advice to Member States on ways to contain healthcare 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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