Theorem Clinical Research

Ethics/Regulatory

2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

Wednesday, December 17, 2014 03:15 PM

Margaret A. Hamburg, M.D., commissioner of the FDA, spoke about 2014 drug approval data on the FDA’s official blog FDAVoice.

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Quest Diagnostics

FDA announces Pharmacy Compounding Advisory Committee members

Wednesday, December 17, 2014 12:29 PM

The FDA has announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members—12 voting and two non-voting—who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

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Congress includes $25 million increase for Alzheimer’s research funding in spending bill

Monday, December 15, 2014 12:33 PM

The 2015 U.S. government spending package, known as the cromnibus, includes an increase of $25 million for the National Institute on Aging (NIA), with an expectation that much of the funding would support additional research into Alzheimer’s and dementia.

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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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AiCure
CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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