Ethics/Regulatory

14 indicted in connection with 2012 nationwide fungal meningitis outbreak

Friday, December 19, 2014 02:29 PM

The Justice Department unsealed a 131-count criminal indictment in Boston in connection with the 2012 nationwide fungal meningitis outbreak. Barry J. Cadden, owner and head pharmacist of New England Compounding Center (NECC), and NECC’s supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia.   

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Seven more research organizations earn AAHRPP accreditation

Friday, December 19, 2014 01:02 PM

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited seven more organizations: four in the U.S. and three in Asia, including the first organization in Thailand.

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New FDA-sponsored research: National and international device registries needed

Thursday, December 18, 2014 11:23 AM

Most Americans will be exposed to a medical device during their lives and tens of millions will receive an implantable device. However, public health and regulatory agencies in the U.S. and internationally acknowledge there are gaps both in the ability to track these devices and to provide the public the accurate, evidence-based information consumers need to improve their health and make informed care decisions.

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Research, generic/biosimilar industries call for integrated strategy for Europe

Thursday, December 18, 2014 11:14 AM

Ahead of the adoption of the European Commission Work Program, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic Medicines Association (EGA) have reiterated their joint Europe 2020 strategy submission for an industrial policy for the globalization era and the value it places in the pharmaceutical sector. The joint submission highlights key proposals on how to successfully integrate the pharmaceutical sector for an industrial policy that will boost European health and wealth alike.

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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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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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May 18

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

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

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May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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