Regulatory Articles

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).

Putting Safety at the Center of Clinical Studies

Mar 27, 2017

By Cheryl Key

As competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, pharma companies are exploring safety as a product differentiator during the clinical trial process.

Regulatory News

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.

EMA Relocation Worries Intensify in the Final Stages of the Decision

Tensions mount across the European pharmaceutical scene over the fate of the EMA with just weeks before the final decision is going to be made on where it will be moved to.

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