Ethics/Regulatory

FDA, EMA reviewing Sanofi’s Multaq

Monday, July 25, 2011 01:54 PM

U.S. drug regulators are reviewing data from a halted clinical trial of Sanofi's key heart drug Multaq to determine how it may affect patients taking it for approved indications, according to Reuters.

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FDA pledges to work with medical entrepreneurs

Tuesday, July 19, 2011 01:02 PM

The head of the FDA pledged to work more closely with small medical technology companies, which have spent the last year alleging that the agency is needlessly slowing approvals of new drugs and devices, according to the Associated Press.

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Despite seeing benefits, industry awaits FDA final guidelines before adopting adaptive design trials

Monday, July 18, 2011 08:02 AM

The promise of adaptive design clinical trials exists, with increased ethical treatment of patients, greater likelihood of finding the optimal dose and shortened study duration. But a variety of sponsor and CRO barriers—lack of experienced personnel with the required skills and knowledge, misunderstood benefits and greater complexity of design and trial implementation—have slowed their widespread adoption.

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FDA names new deputy commissioner for medical products and tobacco

Friday, July 15, 2011 10:52 AM

The FDA has named former Dartmouth Medical School Dean Stephen Spielberg to the newly created position of deputy commissioner for medical products and tobacco, according to an internal letter sent to FDA employees obtained by Reuters.

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Frances unveils drug regulation overhaul

Friday, July 15, 2011 10:10 AM

Health minister Xavier Bertrand says new regulation will strengthen pharmacovigilance, create greater transparency and more declaration of interests at all levels of regulation and government, according to InPharm.

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EMA releases paper on biomarker use for comment

Thursday, July 14, 2011 12:43 PM

The European Medicines Agency (EMA) has put out for consultation a reflection paper on the use of pharmacogenomic biomarkers as patient selection and treatment stratification tools in drug development, according to PharmaTimes.

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FDA proposes targeted drug testing guidelines

Wednesday, July 13, 2011 10:53 AM

Targeted drugs or therapies up for regulatory approval would have to be reviewed simultaneously with the diagnostic devices they rely on, according to a proposed policy issued by the FDA, according to Reuters.

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EMA to release monthly adverse event reports

Wednesday, July 13, 2011 10:08 AM

The EMA will start producing monthly adverse event reports for the public as part of its plans to open up access to drug information, according to InPharm.

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FDA eases rules for Alzheimer’s experiments to speed new treatments for dementia

Tuesday, July 12, 2011 12:35 PM

The FDA is making it easier to test new Alzheimer’s drugs, hoping to speed progress toward new treatments for the mind-robbing disease, according to an Associated Press report.

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Australian government launches review of health and medical research

Tuesday, July 12, 2011 12:18 PM

The Australian government has issued the draft terms of reference for a strategic review of health and medical research, according to PharmaTimes.

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