Regulatory Articles

Jun 28, 2015
Applied Clinical Trials
The era of personalized medicine is fast approaching and, in many therapeutic areas such as oncology, is already underway.
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.

Regulatory News

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.

FDA’s Social Media Consumer Outreach Up

The pilot involved several CDER employees working together with OEA employees to respond to drug related inquiries posted on FDA’s Facebook page.

Acorn Regulatory Offers EU Programs for U.S. Drug-Device Sponsors

Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, has customized programs to help U.S. manufacturers of drug-device combinations in meeting European regulatory approvals.