Ethics/Regulatory

The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

[Read More]

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.

[Read More]

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.

[Read More]

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.

[Read More]