Regulatory Articles

Redefining the Sciences of Drug Safety

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 Clinical Trial Regulation: Headway and 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.

TransCelerate’s eLabeling Initiative

Apr 22, 2015

By Moe Alsumidaie

TransCelerate recently announced a new initiative focused on eLabeling in clinical trials. The eLabels Initiative is expected to improve label usage for patients, streamline labeling approaches at sites and create opportunities to decrease timelines in the investigational supply chain resulting in cost efficiencies for sponsors.

FDA’s Expedited Review Process: The Need for Speed

Mar 11, 2015

By Shahza Somerville, Jessica Holden Kloda

The FDA works to protect public health by balancing the requirements for extensive safety and efficacy data prior to approval, and the need to expeditiously issue approval decisions to ensure medicines that could save or dramatically improve patients’ lives are available as soon as possible.

Regulatory News

Is the Sunshine Act Pushing Research Out of US?

An analysis by Life Science Compliance Update of the U.S. government's Open Payments database shows that industry spending on U.S-based clinical research has dropped 32% in the first year-over-year comparison since Open Payments data started to be collected.

EORTC Prepares to Show How to Navigate Regulatory Triangle

How can you navigate the regulatory triangle safely?

EMA Aims to Give New Impetus to Pediatric Trials

The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan.

50 Years of EU Pharma Legislation

To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organizing a one-day conference that will take place in Brussels September 28.

Navitas Launches Latin American Regulatory Operations Hub

Navitas, a regulatory service provider, announced that it has opened a new Latin America hub in Bogota, Colombia. Navitas' expansion into Latin America offers bilingual resources (Spanish and English) and provides document, report and submission level publishing for simple and complex submission applicatioms.