Ethics/Regulatory

Proposed NIH policy calls for a single IRB to accelerate multi-centered trials and reduce redundancy

Friday, December 5, 2014 12:40 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The National Institutes of Health (NIH) officially has backed a draft policy calling for a single IRB for multi-site reviews of NIH-supported clinical trials—a streamlined strategy it says will accelerate trials without compromising safety.

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SEC suspends trading in companies touting Ebola-related prevention/treatment operations

Monday, November 24, 2014 02:49 PM

The Securities and Exchange Commission has suspended trading in four companies that claim to be developing products or services in response to the Ebola outbreak, citing a lack of publicly available information about the companies' operations.

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HHS, NIH to enhance transparency of clinical trial results

Friday, November 21, 2014 11:31 AM

The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to reporting requirements for clinical trials subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

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Australia, New Zealand cancel agreement for joint therapeutic regulator

Friday, November 21, 2014 11:21 AM

Peter Dutton, MP, Minister for Health for Australia, and the Jonathan Coleman, Minister of Health for New Zealand, have announced their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

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EMA revises policy on conflicts of interest

Friday, November 21, 2014 11:19 AM

The EMA has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect a more balanced approach to handling conflicts of interests that aims to effectively restrict the involvement of experts with possible conflicts of interests in the agency’s work, while maintaining EMA’s ability to access the best available expertise.

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EUCROF states position on new clinical trials regulation

Friday, November 14, 2014 10:48 AM

The European CRO Federation (EUCROF), which represents 300 member CROs, has released proposals on the early publication of clinical trial information, balancing the public’s need for transparency and innovators’ intellectual property and confidentiality rights.

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U.S. government institutes funding pause on gain-of-function research

Wednesday, October 29, 2014 01:39 PM

The U.S. government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS and MERS viruses in order to develop a new federal policy regarding the funding of this research, announced Francis S. Collins, M.D., Ph.D., NIH director, in a statement. U.S. government agencies will institute a pause on the funding of any new studies involving these experiments.

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Treasury’s tax inversion changes scuttle some big biopharma mergers, modify others, prompting calls for Congressional corporate tax reform

Thursday, October 23, 2014 03:50 PM

By Ronald Rosenberg
CenterWatch Staff Writer

The widely-discussed $54.6 billion acquisition of Dublin-based Shire by AbbVie is officially canceled, having crumbled after a notice by the U.S. Treasury Department to tighten tax rules that deter U.S. companies from moving their legal headquarters to countries with lower business taxes.

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INC Research to perform FDA due diligence audit for Provectus

Thursday, October 23, 2014 01:10 PM

Provectus Biopharmaceuticals, a Knoxville, Tenn.-based development-stage oncology and dermatology biopharmaceutical company, has retained INC Research, a Raleigh, N.C.-based global CRO, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.

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MHRA sets up ‘one-stop shop’ for advice on regenerative medicine

Thursday, October 16, 2014 08:00 AM

The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovation Office has set up a portal for all regulatory queries concerning regenerative medicines, the Regenerative Medicines Regulatory Advice Service. A “one-stop shop” service, it will provide a single point of access from the four regulators in the field: the Human Tissue Authority (HTA), the Human Fertilization and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), which will provide a coordinated single response service for free regulatory advice.

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CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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