Ethics/Regulatory

Western Institutional Review Board receives ISO 9001:2008 certification

Monday, March 16, 2015 08:00 AM

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software, has announced Western Institutional Review Board (WIRB) has been certified to ISO 9001:2008 by BSI, confirming it operates an excellent quality management system.

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U.K. industry paid $456.7M in 2014 to underwrite medicines bill

Friday, March 13, 2015 12:28 PM

The Association of the British Pharmaceutical Industry (ABPI) and the U.K. Department of Health have announced a fourth quarter payment from industry of $119.3 million to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme (PPRS). This takes the total payment made by industry during 2014 to $456.7 million.

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FDA approves first biosimilar Zarxio from Sandoz

Friday, March 6, 2015 12:24 PM

Sandoz, a Novartis company, has became the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilar pathway established under the Biologics Price Competition and Innovation Act.

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FDA launches drug shortages mobile app

Thursday, March 5, 2015 12:34 PM

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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Pearl IRB granted AAHRPP accreditation

Thursday, February 26, 2015 03:32 PM

Pearl IRB, an Indianapolis-based provider of central IRB review services, has received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

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Obama outlines his Precision Medicine Initiative

Friday, January 30, 2015 12:31 PM

Building on President Obama’s announcement in his State of the Union Address, the administration is unveiling details about the Precision Medicine Initiative, a new research effort to revolutionize how to improve health and treat disease.

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Report: regulatory innovation should adapt to new health economy

Wednesday, January 28, 2015 01:25 PM

Consumers and drug and device manufacturers are changing practices and shifting attitudes toward the FDA.

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EMA recommends suspending medicines over flawed studies

Monday, January 26, 2015 12:43 PM

A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

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Second Turkish man sentenced for smuggling counterfeit cancer drugs

Monday, January 26, 2015 12:41 PM

The U.S. District Court of the Eastern District of Missouri has sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin.

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Sen. Warren to push law establishing “swear jar” concept for drug companies facing fraud penalties to help fund NIH

Friday, January 23, 2015 02:40 PM

Democratic Senator Elizabeth Warren of Massachusetts told the audience at a national healthcare advocacy conference Thursday she will introduce a new law—the Medical Innovation Act—to advance medical research.

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May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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