Regulatory Articles

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.
Applied Clinical Trials: Dec 01, 2013
Global action and collaboration is needed to tackle the threat of antibiotic-resistant diseases.

Regulatory News

ClinRegs Navigates Country-Specific Trial Regulatory Info

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), has launched ClinRegs, a public website designed to help clinical researchers navigate country-specific regulatory information as they plan and implement clinical trials.

BRANY Announces 5-Year Accreditation

BRANY has successfully continued its Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Western Institutional Review Board Receives ISO Certification

WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that its Western Institutional Review Board® company has been certified to ISO 9001:2008 by BSI.

Medical Device Sponsor Receives FDA Approval Using Target Health's Services

?Lund, Sweden-based Dignitana, a manufacturer of medical cooling devices, engaged CRO Target Health in 2011 toward its approval of DigniCap® System, its product to protect cells and hair for patients in chemotherapy treatment.

Pfizer Deploys Pharmacovigilance Solution to US Market

MyMeds&Me, a SaaS provider of web-based adverse event and product quality complaint capture solutions for life sciences, announced the deployment of its Reportum® solution across all Pfizer safety call center sites in the United States.