Category Archives: Regulatory

EFPIA’s “Integrated Strategy”: Out of the Frying Pan, Into the Fire?

It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the […]
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EMA Responds Robustly to Conflict-of-Interest Claims

By Philip Ward, Applied Clinical Trials. The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.
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Industry Seeks Clearer Track-and-Trace Standards

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain, writes Jill Wechsler. Beginning Jan. 1, 2015, manufacturers and distributors will need to have in place systems able to transmit information on prescription drug movement in the United States from plant, to packagers and various wholesalers and distributors, and ultimately to dispensers. FDA […]
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Experts Tell Congress How to Streamline Clinical Trials

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process, according to leaders of biopharmaceutical research community. As part of its 21st Century Cures Initiative, the House Energy & Commerce Committee called on representatives of industry and academia to present strategies for reducing regulatory oversight, speeding up […]
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EMA Delays Adoption of Policy on Publishing Trial Data

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October. […]
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