Ethics/Regulatory

EMA releases data integrity guidance

Monday, August 15, 2016

The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.

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ICER addresses misconceptions about value assessment goals and methods

Monday, August 15, 2016

The Institute for Clinical and Economic Review (ICER) has released a new publication to support the ongoing public conversation about its goals and the methods for evaluating the value of new drugs, devices, and other health system innovations. This publication, “Addressing the Myths About ICER and Value Assessment,” answers questions about ICER’s history, mission and methods while addressing misperceptions that may impede the kind of collaboration that is at the heart of ICER’s work.

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EMA publishes adaptive pathways report

Tuesday, August 9, 2016

The EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients’ unmet medical needs.

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EMA updates organizational structure

Tuesday, August 2, 2016

The EMA has announced organizational adjustments and important strategic amendments of its corporate management structure that will result in a leaner, more streamlined architecture and improved administrative support. Building on the 2013/2014 reorganization of the agency, the changes fine-tune the re-engineered organizational model to further improve efficiency and effectiveness of EMA’s operations. All changes will come into effect on September 1, 2016.

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Alere hit with subpoena for Medicare billing practices

Thursday, July 28, 2016

Investors were temporarily shaken after news of a federal investigation into Medicare billing practices. Alere received a U.S. Department of Justice subpoena addressed to Alere Toxicology Services on July 1, 2016. The subpoena seeks records related to Medicare, Medicaid and Tricare billings dating back to 2010 for patient samples tested at the company’s Austin, Texas pain management laboratory.

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EMA suspends Semler’s medicines over flawed studies

Monday, July 25, 2016

The EMA has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. The Agency has also recommended that medicines currently being evaluated for authorization and which rely only on bioequivalence studies from this site should not be authorized until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

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EMA to revise guidance on first-in-human clinical trials after Bial trial deaths

Monday, July 25, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper which has been released for public consultation. Comments on the proposals should be sent to FIH-rev@ema.europa.eu until September 30 using the form provided.

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