Ethics/Regulatory

FDA issues draft guidance for IRBs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The FDA on Nov. 20 issued a draft guidance titled Draft Guidance for IRBs, Clinical Investigators and Sponsors--IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the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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Codeine in certain children may lead to rare, but life-threatening AEs or death

Wednesday, August 15, 2012 01:48 PM

The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy or adenoidectomy for obstructive sleep apnea syndrome.

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Sen Gillibrand announces bill to spur growth of science and technology jobs

Friday, August 10, 2012 02:58 PM

Sen. Kirsten Gillibrand (D-N.Y.) announced legislation to spur the growth of new science and technology jobs in Western New York and across New York. The “America Innovates Act” would help scientists and researchers secure valuable resources and training to turn their discoveries into marketable products, new high-tech companies and jobs.

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