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Latest News | 24 May 2012

Regulatory Focus: Week in Review (21-25 May)

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Regulatory Focus is proud to bring you another edition of Week in Review—a recap of the global regulatory news space for the preceding week. We cover the news and regulatory intelligence from around [Read More...]

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Latest News | 24 May 2012

FCC Approves First-in-World Plan to Dedicate Spectrum to Networked Medical Devices

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In an expected move, the Federal Communications Commission (FCC) approved a plan to dedicate a new band of shared spectrum to an emerging class of medical devices known as Medical Body Area Networks [Read More...]

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Latest News | 24 May 2012

Franck’s Pharmacy Issues Extensive, ‘Urgent’ Recall After Facility Contamination

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Pharmaceutical compounder Franck’s Pharmacy issued what it called an “urgent” recall of all of its sterile human and veterinary products after an inspection by the US Food and Drug Administration [Read More...]

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Latest News | 24 May 2012

Australia Looking to Change Layout of Package Labeling

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Australia’s Therapeutic Goods Administration (TGA) is calling for comments on a new proposed review to change the way labeling information is situated on medicinal product packaging.The proposed [Read More...]

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Latest News | 24 May 2012

Warning Letter Analysis: Animal Food Manufacturer Cited for Marketing Violations

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A warning letter released by the US Food and Drug Administration (FDA) on 24 May cites a manufacturer of animal food products for promoting its products using claims restricted by law to animal drugs [Read More...]

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Latest News | 24 May 2012

USP Releases Overhaul of Impurities Testing Standards

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The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products.The standards, [Read More...]

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Latest News | 24 May 2012

BREAKING: After Gauntlet of Setbacks, Senate Passes Amended User Fee Bill

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BREAKING UPDATE: In a 96-1 vote, the US Senate has passed the Food and Drug Administration Safety and Innovation Act. The bill will now wait to be merged with the House of Representatives' version of [Read More...]

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Latest News | 24 May 2012

Advisory Committee Votes Against Label Expansion for J&J/Bayer’s Xarelto

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The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer’s co-developed oral anticoagulant drug Xarelto (rivaroxaban), [Read More...]

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Latest News | 24 May 2012

Study Calls for Canada to Boost Funding for Clinical Trials

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A study released in the Canadian Medical Association Journal (CMAJ) is calling for the Canadian government to boost funding for clinical trials, saying it provides “scant support” for randomized [Read More...]

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Latest News | 24 May 2012

UK Organizations Band Together to Form New Clinical Trial Transparency Standards

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A number of prominent UK healthcare organizations have banded together to form a new set of principles meant to set a new voluntary standard for the reporting of clinical trial data, reports [Read More...]

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