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Latest News | 7 March 2013

Medtronic Renal Denervation Device Accepted for Joint FDA-CMS Review

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Medical device manufacturer Medtronic has announced that its Symplicity Renal Denervation System has been accepted under a relatively new program that will see the device concurrently reviewed by both Read More...


Latest News | 4 February 2013

Long-Awaited Sunshine Act Regulation Released

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The US Centers for Medicare and Medicaid Services (CMS) have released a long-awaited rule that would require all pharmaceutical, medical device and biopharmaceutical companies to report transfers of Read More...


Latest News | 23 January 2013

Senator Calls--Again--for White House to Release Sunshine Act Rules

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A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are Read More...


Latest News | 29 November 2012

Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off

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Signs are emerging that a long-awaited landmark regulation governing the transparency of gifts given to medical practitioners by industry has entered its last clearance stage before final Read More...


News Latest News | 29 August 2012

Trade Associations Want Time Before Sunshine Act Begins

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The Centers for Medicare and Medicaid Services (CMS) is prepared to publish a final rule for the Physicians Payments Sunshine Act, but some trade associations are asking for more time before Read More...


Latest News | 8 May 2012

CMS Announces Planned Data Collection Under Sunshine Act Delayed Until 2013

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The US Centers for Medicare and Medicaid Services (CMS) announced 3 May it would postpone a planned data collection mandated by the Physician Payments Sunshine Act (PPSA), saying it would not collect Read More...


Latest News | 2 May 2012

CMS Coverage Decision Based on FDA Parallel Review Program

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A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an Read More...


Latest News | 27 April 2012

New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

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The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint, which charts the course for the future development of bioscience research in the US and addresses Read More...


Latest News | 17 February 2012

With Drugs Scarce, Attention Turns to Labeling Regulations

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Worsening shortages of some critical drugs are causing some groups to criticize US Food and Drug Administration (FDA) and Center for Medicare and Medicaid Services (CMS) regulations that the groups Read More...


Latest News | 30 January 2012

DHHS Releases New Regulations on Medicaid Covered Outpatient Drugs

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The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by 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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