Ethics/Regulatory

Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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WIRB Copernicus Group

PhRMA endorses FDA Safety Over Sequestration Act

Monday, July 29, 2013 11:28 AM

The Pharmaceutical Research and Manufacturers of America (PhRMA) has endorsed the FDA Safety Over Sequestration Act of 2013. PhRMA represents U.S. biopharmaceutical research and biotechnology companies devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.

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EFPIA, PhRMA release joint principles for responsible data sharing

Wednesday, July 24, 2013 01:41 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have endorsed joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

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Kantara Initiative, SAFE-Biopharma support NSTIC principles

Wednesday, July 3, 2013 10:41 AM

The Kantara Initiative, which helps organizations establish verified trust in use of digital identities for business and government services, and SAFE-Biopharma, which provides a global digital identity and digital signature standard for the life sciences, have pledged to adopt the four principles of the National Strategy for Trusted Identities in Cyberspace (NSTIC), the White House initiative to improve the privacy, security and convenience of sensitive online transactions.

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WIRB-Copernicus Group, UL Quality, Compliance and Learning partner

Friday, June 28, 2013 01:50 PM

The WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for human research, has partnered with UL Quality, Compliance and Learning (formerly EduNeering), a technology-driven compliance learning solutions company, to bring educational opportunities to clinical research professionals.

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AAHRPP, ViS Research Institute collaborate

Wednesday, June 26, 2013 02:51 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) and the ViS Research Institute have allied to protect research participants by providing easy access to information on the quality and standards of organizations that conduct clinical trials.

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Parliament committee adopts amendments to proposed clinical trial regulation

Monday, June 3, 2013 11:35 AM

The European Parliament’s Committee on Environment and Public Health has unanimously adopted reporter Glenis Willmott’s amendments to the Commission’s proposed regulation on clinical trials, including provisions requiring sponsors to publish full clinical study reports once a marketing authorization decision has been taken.

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FDA lifts clinical hold on anthrax vaccine program

Thursday, May 30, 2013 03:24 PM

PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, said the FDA has lifted the clinical hold previously placed on a proposed phase II study of SparVax, a next generation recombinant anthrax vaccine.

"Anthrax has been identified as one of the foremost potential biological threats to the nation,” said Eric I. Richman, president and CEO.  “The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled. Next-generation anthrax vaccines like SparVax, which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery.”

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Bio-Optronics, Schulman Associates IRB to simplify clinical trial management

Friday, May 3, 2013 11:30 AM

Bio-Optronics, a software and services provider, and Schulman Associates IRB, an international, AAHRPP-accredited independent IRB, announced their partnership and their newly integrated regulatory compliance module for the Clinical Conductor Enterprise CTMS application. This collaboration offers Clinical Conductor Enterprise CTMS users streamlined IRB interactions from one centralized location.

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EMA publishes initial list of medicines under additional monitoring

Friday, April 26, 2013 10:22 AM

The European Medicines Agency has published the initial list of medicines that are subject to additional monitoring, representing an important deliverable of the new European pharmacovigilance legislation.

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