Regulatory Articles

Apr 21, 2015
Applied Clinical Trials
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.
Mar 10, 2015
Applied Clinical Trials
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.
Feb 27, 2015
Applied Clinical Trials
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.
Sep 30, 2014
Applied Clinical Trials
Reshuffling to heavily impact life sciences policy in Europe.
Jul 31, 2014
Applied Clinical Trials
There are 7,000 rare diseases affecting approximately 350 million people around the world.
Jul 14, 2014
Applied Clinical Trials
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.
Jun 23, 2014
Applied Clinical Trials
Pharmacovigilance is the next frontier for outsourcing in the pharmaceutical and biologics industry.
May 31, 2014
Applied Clinical Trials
Claims of success for pharmacovigilance are under question, but hopes are higher for new clinical trials rules.
May 19, 2014
Applied Clinical Trials
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.
Mar 31, 2014
Applied Clinical Trials
The advent of new drugs for tuberculosis is posing some interesting challenges for regulators in Europe.

Regulatory News

Sponsor Selects TrialScope Tool for Clinical Trial Disclosure

TrialScope, a provider of clinical trial transparency and compliance solutions, announced a clinical trial sponsor has selected its PharmaCM clinical trial disclosure platform.

Data Manipulations in India Cause EU Suspensions

The manipulation of data from studies conducted in India have led the European Medicines Agency (EMA) to confirm suspensions of a number of medicines.

inVentiv Health Expands Global Regulatory Compliance Services

inVentiv Health, a global provider of clinical development and comprehensive commercialization services, announced expansion of compliance products and services to assist biopharmaceutical companies conducting non-interventional studies globally.

EMA Tightens Rules for Committee Members and Experts

The European Medicines Agency (EMA) has updated its rules on declarations of interests for scientific committee members and experts.

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).