Ethics/Regulatory

CPhI Worldwide proposes new FDA quality metrics system

Monday, September 26, 2016

CPhI Worldwide, organized by UBM EMEA, has announced the findings of part i of the 2016 CPhI Annual Report on potential new approaches to improve quality and manufacturing process in pharmaceutical production ahead of CPhI Worldwide 2016 in Barcelona. Five World-renowned experts—Ajaz Hussain, Girish Malhotra, Brian Carlin, Pabir Basu & Thomas Friedli—propose improved methods to how industry evaluate and consider quality in the pharmaceutical industry, making a number of key recommendations.

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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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Advancing patient protection through proposed Common Rule changes for informed consent

Thursday, September 1, 2016

Research practitioners eagerly anticipate finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule, which is scheduled to be released in September 2016. Many experts speculate that the revised policy may not be published as expected, yet there appears to be consensus that change in the rules governing human subjects is inevitable; the question remains as to what will be the final rulemaking and the impact on research practice. More than five years have passed since the impending change was announced in an Advance Notice of Proposed Rulemaking (ANPRM) on July 26, 2011 [FR 2011; 76(143): 44512-44531]. After consideration of substantive public debate, the U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies published a Notice of Proposed Rulemaking (NPRM) with prospective revisions to the Common Rule on September 8, 2015 [FR 2015; 80(173): 53933-54060]. Stakeholders have carefully reviewed the proposed revision, provided essential feedback during an extended open comment period, and continued to consider the implications of potential new requirements as they await publication of a final rulemaking.1,2

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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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GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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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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