Ethics/Regulatory

EMA to revise first-in-human clinical trials guideline

Friday, November 18, 2016

The EMA, in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIH-rev@ema.europa.eu using the template provided.

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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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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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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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