Regulatory Articles

6 Reasons Why Your Drug Could Be Put on Clinical Hold

Oct 02, 2015

By Applied Clinical Trials Editors

In this article, Characteristics of a Successful IND, IDE the author discusses ways in which your drug or device could be put on hold.

Characteristics of the Successful IND or IDE

Sep 17, 2015

By Brian D. Bollwage, JD

Tips for avoiding a clinical hold.

Drug Safety Subspecialties Grow

Aug 26, 2015

By Dr. Magalie Emile-Backer

Innovative surveillance tools and technologies have transformed the field of drug safety into a more proactive, dynamic analytical process.

New EU CT Reg: Headway, Concerns

Aug 26, 2015

By Lisa Henderson

While approved last year, it does not apply earlier than May 2016—leaving interested parties only nine months to prepare for its arrival.

Personalized Medicine and Companion Diagnostics

Jun 29, 2015

By Brian D. Bollwage, JD

The era of personalized medicine is fast approaching and, in many therapeutic areas such as oncology, is already underway.

Regulatory News

Guido Rasi Enjoys Surprise Reincarnation at EMA

Rasi was forced to step down in November 2014 by the EU Civil Service Tribunal after a panel of experts found the European Commission (EC) had used improper procedures when it had selected him back in 2011.

The Prostate Cancer Clinical Trials Consortium Selects WIRB-Copernicus for IRB Services

PCCTC will utilize its services for the review of its cancer research protocols and related study documents.

FDA Promotes Its Scientific Mission

Washington correspondent Jill Wechsler reports on Janet Woodcock's explanation to Congress last week on the FDA’s lengthy and deliberative process for issuing important policy advisories on biosimilar naming, labeling and interchangeability.

BioClinica Acquires Synowledge

Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events.

Adverse Event Reporting by HCPs Problematic

An analysis of 10.2 million adverse report records filed with the FDA along with survey of 123 health professionals by Tufts CSDD, found voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient.