Louie, PhD, research director, of IDC Health Insights Life Science R&D Strategy and Technology research, said, "The drug safety
services space within the life sciences industry has matured and is increasingly a mainstream contributor to helping to advance the industry forward.
In the new position, Dr Sheng will be responsible for the development and implementation of the company's drug safety
surveillance and clinical research strategy, as well as management and oversight of its clinical development and drug safety
programmes, reporting to its vice president of clinical research, Kristine Erickson, OD, PhD.
For more information about DSN's expanded services, please visit Drug Safety
Navigator's website (www.
Nostrapharmus predicts that during the next 5-10 years drug safety
operations will become almost completely commoditized.
The opening of the Sao Paulo Drug Safety
Center enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized Drug Safety
services globally, by growing and strengthening our overall safety team," noted Dr.
Already this year, reform of China's drug safety
system has taken place.
The guidance describes the various methods FDA currently uses to communicate established and emerging drug safety
information to the public.
Increased funds would be available for agency drug safety
activities for medications as long as they remain on the market, and would add 82 employees to perform post-market safety work.
This would include MedWatch reporting staff and Drug Safety
Oversight Board staff.
The drug safety
board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.
Although it jeopardizes public health, this kind of data filtering is unlikely to end unless government regulators get more control over the monitoring of drug safety
, the critics argue.
Many of the conventional biomarkers used in preclinical drug safety
studies are either insensitive, nonspecific, or they appear late in the pathogenesis of the lesion and, as such, qualify only as reporters or indicators of toxicity.