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Latest News | 13 February 2013

Government Report Shows Endemic Deficiencies in REMS Assessments

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A new report just published by the Department of Health and Human Services (DHHS) claims that the US Food and Drug Administration (FDA) lacks sufficient data to determine whether one of its flagship Read More...


Latest News | 12 February 2013

'Record-Breaking Year' for Fraud Recovery Has Roots in Regulatory Missteps

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2012 was a record year for regulatory-related pain and government gain, claims a new report out from the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the Read More...


Latest News | 6 December 2012

Government Report Details FDA's Progress, Failures in Implementing Improvements

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The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)is many things: an investigator of programs, a finder of fraud and a recommender of program improvements. A new Read More...


Latest News | 29 November 2012

OIG Report Details Scope of Fines Levied on Pharmaceutical Manufacturers in 2012

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The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office charged with investigating potential legal violations and recovering funds for taxpayers, has Read More...


Latest News | 11 October 2012

Four Former Executives Barred from Federal Programs for Unauthorized Human Testing

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Four executives once associated with bone product and medical device manufacturer Synthes will be barred from participating in any federal healthcare program after serving prison time for what Read More...


Latest News | 3 October 2012

Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

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Two new reports released by the US Department of Health and Human Services’ (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with Read More...


Latest News | 3 October 2012

Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

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The US Department of Health and Human Services’ (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of Read More...


Latest News | 3 July 2012

GSK Settles Charges, Agrees to Record-Setting Fine

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British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used Read More...


Latest News | 18 June 2012

Agency Looks to Overhaul Voluntary Fraud Reporting Program

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It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve Read More...


Latest News | 5 June 2012

Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report

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A new government report looking at scientific disagreements within the US Food and Drug Administration’s (FDA) medical device branch recommends a number of changes at the agency after a series of 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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