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Week in Review, July 9, 2014

CMS makes changes to reporting deadlines and requirements, Canada continues to collect date about the effects of off-label use of drugs, and Medicines Australia updates its Code of Conduct. You scream,...

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Week in Review, July 22, 2014

The Minnesota Board of Pharmacy confirms that payments to nurse practitioners and PAs must be reported, the FDA issues more Warning Letters, a grand jury indicts FedEx for shipping drugs for illegal...

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News Week in Review, July 29, 2014

Physicians find confusion instead of data on Open Payments, a judge refuses to dismiss the false claims case involving Thalomid, FedEx is facing arraignment this week for shipping illegal drugs, and...

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Week in Review, August 5, 2014

Industry groups ask CMS to help clarify context of physician payment data, a study finds most physicians have yet to visit the Open Payments website, another medical device company settles a False...

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Week in Review, August 19, 2014

The widespread use of DPAs and NPAs in bribery cases raises legal concerns, CMS shuts down Open Payments to correct data problems and subsequently announces it will actually withhold one third of the...

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Week in Review, August 27, 2014

Another industry organization calls for a change to the Sunshine Act, manufacturers claim data entered into Open Payments is now lost, the Supreme Court is petitioned to review the definition of...

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Week in Review, September 10, 2014

PhRMA pushes for dismissal of Integrilin off-label case, a recent FCPA settlement reveals a shift in DOJ thinking, European companies are not sure how to handle informed consent with EFPIA, and another...

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Week in Review, September 17, 2014

A new study reveals surprising information about FDA panelists and their ties to manufacturers seeking regulatory approval, the DOJ files a False Claims suit against a neurosurgeon and a spinal implant...

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Week in Review, September 30, 2014

PhRMA and the DOJ argue the details of the Integrilin case, sentences and a fine are handed down in the GSK Chinese bribery case, more elected officials weigh in on the removal of the CME exclusion...

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Week in Review, November 5, 2014

The OECD questions Japan’s bribery law, OIG releases its 2015 Work Plan, CMS hopes to clarify the issues with data mingling, and Biomet settles False Claims Act charges against one of its subsidiaries....

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Week in Review, November 26, 2014

Time to head over the river and through the woods to grandmother’s, or somebody’s house, for turkey, gravy, stuffing and pumpkin pie! Thanksgiving is almost here! The Week in Review staff is excitedly...

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Week in Review, December 10, 2014

The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system. Well,...

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Week in Review, December 16, 2014

Otismed pleads guilty to selling knee replacement cutting guides that had been rejected by the FDA, Senators Hatch and Bennett introduce bill to exempt low risk software from the definition of a...

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2014 Year in Review

2015 is upon us! It seems like only yesterday we were posting our 2014 Compliance Year in Review. Time sure does fly! We here at the Compliance News in Review wish you and yours the best for a happy...

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News Week in Review, January 26, 2015

Senator Warren looks to use pharmaceutical company penalties to support research at the FDA and NIH, a new report reveals that a significant amount of businesses in China pay bribes, a physician...

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News Week in Review, February 18, 2015

Several companies announce settlements of charges related to the False Claims Act, CMS releases new information to help with system registration and data submissions, and the National Coalition on...

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Week in Review, March 6, 2015

A potential new law in California calls for greater drug pricing transparency, consumer advocacy groups and industry trade groups in Europe argue over clinical trial data transparency, a Maine law...

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Compliance Week in Review, March 15, 2015

A French court overturns the fee for service exclusion from Loi Bertrand, a dental company settles with the Vermont AG’s office over failure to report charges, an internal investigation at Teva reveals...

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The 2015 Pharmaceutical Compliance Congress: A Review and Recap

The 12th Annual Pharmaceutical Compliance Congress provided an overflow crowd of rapt attendees with two days of best practices and updates on critical compliance-related topics. While the usual array...

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Compliance News in Review, March 24, 2015

Oregon considers the idea of requiring pharma companies to disclose pricing information, CMS offers Open Payments updates, Sandoz settles with the OIG over alleged pricing data misrepresentations, the...

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