Regulatory Articles

Applied Clinical Trials: Apr 21, 2015
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.
Applied Clinical Trials: Mar 10, 2015
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.
Applied Clinical Trials: Feb 27, 2015
Just two years ago there were more than 100,000 health-related apps available for download just from Apple’s iTunes Store and Google’s Play Store. This year, it is estimated that more than a third or 500 million of the estimated 1.4 billion global smartphone users will have installed some type of mobile medical application.
Applied Clinical Trials: Sep 30, 2014
Reshuffling to heavily impact life sciences policy in Europe.
Applied Clinical Trials: Jul 31, 2014
There are 7,000 rare diseases affecting approximately 350 million people around the world.
Applied Clinical Trials: Jul 14, 2014
With the passage of the Biosimilar Price Competition and Innovation Act in 2009, the U.S. created new pathways for development and approval of biosimilar and interchangeable products.
Applied Clinical Trials: Jun 23, 2014
Pharmacovigilance is the next frontier for outsourcing in the pharmaceutical and biologics industry.
Applied Clinical Trials: May 31, 2014
Claims of success for pharmacovigilance are under question, but hopes are higher for new clinical trials rules.
Applied Clinical Trials: May 19, 2014
One of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
Applied Clinical Trials: Mar 31, 2014
The advent of new drugs for tuberculosis is posing some interesting challenges for regulators in Europe.

Regulatory News

EMA to Scrutinize Trial Results for Malaria Vaccine

The first malaria vaccine candidate (RTS,S/AS01) to reach Phase 3 trials is partially effective against clinical disease in young African children up to four years after vaccination, according to final trial data published in The Lancet, which will now be evaluated by the European Medicines Agency (EMA).

Synchrogenix, CISCRP Partner on Lay Summaries of Clinical Trials

Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials.

EU Consortium Awards Catalent Grant to Pursue Vaccine Advances

Catalent, a global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced that it has received a project grant as part of a consortium.

TrialScope Launches Free EudraCT Results Conversion Service

TrialScope, a clinical trial transparency and compliance solutions provider, announced the availability of Convert, a free online clinical trial data conversion service.

PAREXEL Launches LIQUENT InSight 6.0

PAREXEL introduced the latest version of its Regulatory Information Management (RIM) platform: LIQUENT InSight® 6.0