Regulatory Articles

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

Mar 07, 2018

By Kathleen Sanzo, Phoebe Mounts, Suzanne Bassett

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.

What Pharma Companies Need to Know About FDA's New Draft IVD Guidance

Feb 12, 2018

By Kathleen Sanzo, Michele L. Buenafe

The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.

How to Pick the Right Drug Doses for Pregnant Women

May 17, 2017

By Alice Ke, PhD, David Taft, PhD

The majority of pregnant women are prescribed treatments that can include antibiotics, antivirals and more. However, little to no information is available about the appropriate dose to prescribe or the potential adverse fetal effects.

New Clinical Trials Law in France: Advantages for Medical Device Studies

May 01, 2017

By Victor Bony

The new law on research in France introduces changes for the medical device industry by facilitating the conduct of postmarketing studies. Devices will no longer have to be provided free of charge for low-risk interventional studies making France a possible location for such trials in the future.

Academic Research Under the Clinical Trial Regulation – Partial Relief?

May 01, 2017

By Ernst A. Singer, MD

This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).

Regulatory News

Final Guidance on IRB Written Procedures Issued

The Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.

Plunging Through the Other Brexit Fog: How to Keep the EU Authorization System Running

The operational subject of how the centralized authorization procedure is going to work when the UK is no longer part of the European Union is being discussed.

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