Ethics/Regulatory

HHS provides more information about clinical trials to the public

Tuesday, September 20, 2016

In an effort to make information about clinical trials widely available to the public, the HHS has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological and device products. At the same time, the NIH has issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials, including those not subject to the final rule.

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St. Jude Medical sues Muddy Waters and MedSec

Monday, September 12, 2016

St. Jude Medical, a global medical device company, has filed a lawsuit against Muddy Waters Consulting, Muddy Waters Capital, MedSec Holdings, MedSec and three individual defendants who are principals in these firms, for false statements, false advertising, conspiracy and the related manipulation of the public markets in connection with St. Jude Medical’s implantable cardiac management devices.

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Theranos to appeal CMS sanctions

Monday, August 29, 2016

Theranos, a health technology company, has filed a notice of intent to appeal the sanctions that the Centers for Medicare and Medicaid Services (CMS) imposed last month on the company’s Newark, California, lab.

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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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