Cromos Pharma, where the patients are

Ethics/Regulatory

FDA, new MDIC to develop regulatory science to speed access to medical devices

Monday, December 3, 2012 11:48 AM

The FDA has become part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

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CRF Health eCOA webinar series

EFPIA gives recommendations for clinical trial data transparency

Tuesday, November 27, 2012 02:43 PM

The European Federation of Pharmaceutical Industries and Associations recently held a workshop to give insight into the different views on the sensitive issue of clinical data transparency in Europe.

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FDA issues draft guidance for IRBs

Tuesday, November 27, 2012 11:28 AM

The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.

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EMA investigates Roche's alleged non-compliance with pharmacovigilance obligations

Wednesday, October 24, 2012 09:46 AM

The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

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Leading researchers outline principles for conduct of comparative effectiveness research

Wednesday, September 12, 2012 11:51 AM

A new set of principles developed by a group of leading researchers could help to ensure more consistency in how comparative effectiveness research (CER) is planned and conducted. These guiding principles were published in the September issue of The Journal of Comparative Effectiveness Research.

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CAP-ASCCP make recommendations to stadardize histopathologic terminology, guide optimal biomarker use

Monday, September 10, 2012 10:17 AM

A working group from the Lower Anogenital Squamous Terminology (LAST) Standardization Project, an interdisciplinary project led by the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP), has published consensus recommendations to standardize the histopathologic terminology for squamous epithelial lesions of the lower anogenital tract associated with human papillomavirus and to guide optimal biomarker use, according to Ventana Medical Systems, a member of the Roche Group.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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Expanded IFPMA Code of Practice for pharma industry goes into effect around the world

Tuesday, September 4, 2012 12:44 PM

The International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) expanded Code of Practice has taken effect around the world. Governing how companies interact with healthcare professionals, medical institutions and patient organizations, this new code has been adopted by all IFPMA member companies and member associations.

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EMA to publish and enable access to clinical trial data

Friday, August 17, 2012 09:27 AM

The European Medicines Agency (EMA) will proactively publish clinical trial data and enable access to full data sets by interested parties.

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FDA solicits industry input about open, consensus-based standards

Friday, August 17, 2012 09:19 AM

The FDA is announcing a meeting “Regulatory New Drug Review: Solutions for Study Data Exchange Standards,” on Nov. 5, to solicit input from industry, technology vendors and the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The FDA also is seeking input from stakeholders on pre-meeting questions discussed below. Registration is required in advance and will be limited.

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CWWeekly

April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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The CenterWatch Monthly

March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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