Ethics/Regulatory

Senators introduce bill for streamlined pathway to approval for antibiotics

Friday, December 12, 2014 03:33 PM

U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) have introduced a bill to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly Veterans who have encountered antibiotic-resistant bacteria while overseas.

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PPMD calls for greater transparency, accountability of FDA patient engagement efforts

Wednesday, December 10, 2014 01:16 PM

Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.

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Global policymakers urged to accelerate cancer research, biomedical discovery

Monday, December 8, 2014 01:09 PM

Accelerating the delivery of promising new treatments to patients must be an international priority, according to the National Patient Advocate Foundation (NPAF), a Wash. D.C.-based nonprofit organization providing the patient's voice in improving access to quality cancer care.

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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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2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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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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