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Latest News | 21 May 2012

FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

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The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national [Read More...]


Regulatory Update | 21 May 2012

World: Regulatory Agencies Attend WHO Seminar

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Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate.The meeting, an international [Read More...]


Regulatory Update | 21 May 2012

Brazil: Anivsa Sets Confidentiality Criteria

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A notice (Ordinance No. 748-B/2012) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access [Read More...]


Regulatory Update | 21 May 2012

Brazil: Anivsa Implements Freedom of Information Law

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Greater transparency is an integral part of the reorganization of Brazil’s national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its [Read More...]


Latest News | 21 May 2012

NICE Could ‘Lose Most of Its Authority’ Under New NHS Plan

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Under a new plan put forth by the Secretary of the UK’s National Health Service (NHS), Andrew Lansley, the National Institute for Health and Clinical Excellence (NICE) would no longer direct NHS’s [Read More...]


Latest News | 21 May 2012

Health Canada Approves World’s First Stem-Cell-Based Therapy

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Canadian regulators have approved the world’s first stem-cell-based therapy for a systemic disease, granting Maryland-based Osiris Therapeutics’ Prochymal approval for the treatment of [Read More...]


Latest News | 21 May 2012

Pfizer Recalls 653,000 Bottles of Advil After CGMP Deficiencies Cause ‘Strong Odor’

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New York-based pharmaceutical manufacturer Pfizer has recalled more than 653,000 bottles of its Advil Liqui-Gels pain-reliever after becoming aware of a “strong odor” in the product, reports Dow Jones [Read More...]


Latest News | 21 May 2012

Poll: More Than Half of Americans Favor Increased Regulatory Authority for States

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A poll conducted by Rasmussen Reports finds a slim majority of Americans are in favor of increasing the authority given to states to overrule a decision made by the US Food and Drug Administration [Read More...]


Latest News | 18 May 2012

Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

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The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve [Read More...]


Latest News | 18 May 2012

GAO Finds FDA Employee Review Practices Lagging

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The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration’s (FDA) and found its employee performance [Read More...]


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