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Latest News | 22 May 2012

User Fee Bill Advances to Vote in Senate

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The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate’s iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving [Read More...]


Latest News | 22 May 2012

States to FDA: Appeal Enforcement Discretion Decision

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A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge’s decision in a lawsuit against both FDA and the states’ ability [Read More...]


Latest News | 22 May 2012

Reviewers Express Doubts in Advance of Xarelto Review

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An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson’s (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary [Read More...]


Latest News | 21 May 2012

PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

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The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency’s proposal to review [Read More...]


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...]


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...]


Latest News | 18 May 2012

FCC Unveils Plan to Release New Spectrum for Wireless Medical Devices

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The Federal Communication Commission’s (FCC) Chairman, Julius Genachowski, unveiled a plan to release new wireless spectrum to support the development of Medical Body Area Networks (MBANs), saying the [Read More...]


Latest News | 18 May 2012

FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent

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The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi’s blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the [Read More...]


Latest News | 17 May 2012

Security Agency Warns About Medical Device Vulnerabilities

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The US Department of Homeland Security (DHS) issued a warning on 4 May regarding the potential for medical devices to be compromised by hackers, saying “health care entities need to take [the threat] [Read More...]


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