Ethics/Regulatory

Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

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NICE develops new guidelines for antibiotic resistance

Wednesday, October 15, 2014 01:39 PM

NICE is developing two new guidelines to help tackle the growing threat of antibiotic resistance. The first is on safe and effective antimicrobial stewardship in relation to the use of antimicrobials in health and social care, and the second is a public health guideline that will focus on changing people’s knowledge, attitudes and behaviors in relation to the use of antimicrobials.

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In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

Monday, October 13, 2014 07:00 AM

By Ronald Rosenberg
CenterWatch Staff Writer

Given the choice between talking about Chesapeake Research Review, the highly successful IRB he founded in 1993, or conveying useful information and insights involving bioethics and human subject protection, Felix A. Khin-Maung-Gyi would always choose the latter.

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U.K. public believes not enough is being spent on medicines

Thursday, October 9, 2014 11:35 AM

A new survey has found more than half (52%) of English adults believe that not enough of the NHS budget is being spent on medicines. The survey was commissioned by the Association of the British Pharmaceutical Industry (ABPI), which includes research-based biopharmaceutical companies in the U.K.

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NHS England consults on plans for a sustainable Cancer Drugs Fund

Tuesday, October 7, 2014 10:00 AM

NHS England is proposing changes to the way its Cancer Drugs Fund (CDF) operates, so that it delivers maximum benefit for patients, within the resources available.

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FDA seeks permanent injunction against Pharmaceutical Innovations

Monday, October 6, 2014 03:46 PM

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

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EMA launches new patient-reported suspected side effects web site

Monday, October 6, 2014 03:45 PM

European citizens now can obtain information on suspected side effects, also known as suspected adverse drug reactions, of an additional 1,700 active substances contained in medicines approved in the European Union (E.U.) through a newly launched web site maintained by the EMA.

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FDA takes steps to strengthen cybersecurity of medical devices

Friday, October 3, 2014 11:01 AM

To strengthen the safety of medical devices, the FDA has finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

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EMA to publish clinical reports effective January 2015

Friday, October 3, 2014 10:57 AM

The EMA has decided to publish clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy Oct. 2. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken. The policy will enter into force in January 2015.

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Guideline outlines applications for pediatric investigation plans

Thursday, October 2, 2014 02:29 PM

The European Commission (E.C.) has published a revised guideline on applications for pediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.

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