Category Archives: Regulatory

UK: Lord Saatchi's Innovation Bill Divides Healthcare Community

By Leela Barham. Few would argue with the desirability of innovation — something new, something that delivers value. And innovation in pharmaceuticals is a range from a more convenient way for patients to take a medicine, to treating a disease that couldn’t be treated before. Pretty much everyone will agree that not only do they […]
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"Work to Be Done" on EU Clinical Trials Regulation, Says Industry

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential.
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FDA Wants YOU!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff. Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency, […]
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Is Gender a Drug Safety Issue in the Era of Personalized Medicine?

By Lisa Henderson, Applied Clinical Trials. In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). That was based on evidence […]
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UK: Further Steps Toward Value-Based Assessment

By Leela Barham. The National Institute for Health and Care Excellence (NICE) has finally published the formal consultation on value-based assessment (VBA). VBA is the new VBP, incorporating a wider assessment of value and no longer clearly linking to price in quite the way that some speculated all the way back in 2010 when VBP […]
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