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EMA Releases First Revision to Biosimilar Quality Guidelines Since 2006

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The European Medicines Agency (EMA) announced it has released a newly-revised guideline on the quality of biosimilar medicines and is soliciting comments. The 31 May 2012 guidance, Guideline on Read More...

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Biogeneric

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Follow-on Biologics

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Report: 'Dramatic' Increase in Q1 Medical Device Recalls

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A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls.Medical Read More...

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drug

ExpertRECALL

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Regulatory Update | 14 May 2012

Brazil: South American Countries Driving Regulatory Harmonization

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Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries’ efforts in the region.Both Brazil’s and Read More...

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ICH Finishes Q11 Quality Manufacturing Guideline, Prepares to Notify Regulators

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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 11 May it has finished worked on its Q11 quality drug Read More...

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Biologics

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Chemical

drug

ICH

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EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

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The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified Read More...

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Cells

CHMP

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Clinical Trials

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GMC

Manufacturing

Non-Clinical Testing

Pharmacovigilance

Postmarketing Studies

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Study: Many Clinical Trials Small, of Poor Quality

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Amidst an explosion in the number of clinical trials registered with US regulatory authorities, a new study analyzing clinical trials conducted in the US has found most of them to be relatively small Read More...

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ClinicalTrials.gov

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Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures

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An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure Read More...

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Batch Failure

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Korea, Japan Apply for PIC/S Membership

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The Korean Food and Drug Administration (KFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) have applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Read More...

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drug

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KFDA

Korea

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PMDA

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Manufacturer Raided by US Marshals Service After FDA Finds Contaminated Ultrasound Gel

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The US Food and Drug Administration (FDA) issued a safety communication on 19 April warning consumers about the risks associated with Other-Sonic Generic Ultrasound Transmission Gel after it found Read More...

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bacteria

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CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality

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A new pilot program announced by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aims to dramatically speed up 510(k) medical device reviews for Read More...

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510(k)

CDRH

Device

FDA

Gutierrez

IVD

Medical Device

OIVD

Quality

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Review

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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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