Ethics/Regulatory

Senate Health, Human Services unanimously approve biosimilars legislation

Wednesday, June 10, 2015 11:15 AM

Legislation that allows for greater patient access to more affordable FDA-approved biologic medicines was approved unanimously by the Senate Health, Human Services and Senior Citizens Committee. The bill now moves to review by the full Senate.

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NIH suspends operations in its Clinical Center Pharmaceutical Development Section

Friday, June 5, 2015 10:55 AM

The NIH Clinical Center has suspended operations of its Pharmaceutical Development Section (PDS) due to the discovery of serious manufacturing problems and lack of compliance with standard operating procedures. FDA representatives inspected the PDS and found a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.

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inVentiv Health aims to help sponsors prepare for new E.U. regulations on observational studies

Tuesday, May 26, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

InVentiv Health is cautioning its custom­ers about the potential for confusion that could result from the European Union’s first major regulatory change for clinical trials in 15 years.

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

Monday, May 18, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Congress now has a second chance to act on the Research for All Act, which would bring gender equality to es­sential aspects of medical research.

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Determining the best way to redact sensitive material prior to disclosure

Friday, May 15, 2015 08:00 AM

Transparency and disclosure of clinical trial information has been growing in importance. Providing previously confidential clinical study results for public consumption is a key step toward increasing trust between the public and the industry and encouraging information sharing that could lead to new products or therapeutic approaches.

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WHO draws lessons from Ebola to prepare roadmap for future epidemics

Wednesday, May 13, 2015 12:17 PM

The World Health Organization (WHO) has concluded a meeting on Ebola R&D to look at lessons learned from the outbreak and develop a roadmap for future epidemics.

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New draft of 21st Century Cures Act adds NIH funding as it moves through the legislative process

Monday, May 11, 2015 08:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

The second draft of the proposed 21st Century Cures Act—which aims to accelerate the discovery, develop­ment and delivery of next-generation health products—includes a significant increase in NIH funding, expansion of an FDA patient-focused drug development initiative and removal of some drug exclusivity provisions.

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EMA tightens rules on 'revolving door' for committee members and experts

Thursday, May 7, 2015 12:21 PM

The EMA has updated its rules on declarations of interests for scientific committee members and experts. The updates further strengthen EMA’s policy by restricting involvement of experts in the scientific assessment of medicines if they plan to take up a job in the pharmaceutical industry. The updates also include a revised guide on how to complete the agency’s declaration of interest form.

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EMA scientific advice leads to higher success rates, shorter assessment times

Tuesday, April 21, 2015 07:58 AM

The majority of clinical development plans submitted for scientific advice to the European Medicines Agency (EMA) prior to a marketing authorization application were found not suitable for future benefit-risk assessment. Companies that changed their clinical development plans in accordance with the recommendation from EMA were more likely to be granted a marketing authorization.

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WCG encourages its global research network to use ACTA as clinical trial contract solution

Monday, April 20, 2015 06:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Global IRB WIRB-Copernicus Group (WCG) today said it will encourage the 1,200 members of its global research network to accept and use the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multicenter clinical trials.

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July 27

AB Science warned about putting study volunteers in danger

FDA, Google unite to detect search-data adverse events

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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