Ethics/Regulatory

Congresswoman DeLauro proposes pharma price legislation

Tuesday, October 18, 2016

Congresswoman Rosa DeLauro (CT-03) has announced the Prescription Drug and Medical Device Review Board Act, new legislation that would create a national review board to stop pharmaceutical corporations from charging consumers excessive prices. According to a recent report released by IMS Health Holdings, annual spending on prescription medications has skyrocketed in the U.S. in recent years, and is projected to increase by 22% over the next five years, climbing to as high as $400 billion by 2020.

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New NIH policy ties funding approval to single IRB review

Saturday, October 1, 2016

The wait is over. For the past few years researchers and their respective research institutions have faced the distinct probability that the regulations to protect individuals who agree to volunteer in a research study will be significantly changed. After much discussion on proposed changes to the Common Rule in the Notice of Proposed Rulemaking (NPRM), the Department of Health and Human Services (HHS) is poised to publish a Final Rule. “We expect to publish the Final Rule before the end of the year,” according to an HHS spokesperson.

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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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