The Role of Regulatory Agencies in New Drug Development: A Global Perspective
Regulatory agencies worldwide play a critical role in healthcare as independent reviewers and approvers of applications made by sponsors to…
Regulatory agencies worldwide play a critical role in healthcare as independent reviewers and approvers of applications made by sponsors to…
After issuance of the final guidance document by FDA on Oversight of Clinical Investigations – A Risk-based Approach to Monitoring,…
India is a popular location for clinical research due to the multitude of benefits it offers, including a large patient…
CNS researchers have implemented surveillance strategies from within pharmaceutical companies, through contract research organizations, or by using one of the…
On June 26, 2013, the US Food and Drug Administration (FDA) announced in the Federal Register, the publication of a…
A lot has been written about the Affordable Care Act (ACA) recently. Key provisions are kicking in over the next…
In June 2013, the European Commission published a report on the first five years of the Paediatric Regulation that came…
Alzheimer’s disease (AD) is a debilitating neurodegenerative disorder that mainly affects the elderly population. The prevalence of AD is predicted…
Among adolescents, lifetime prevalence estimates for major depressive disorder (MDD) range as high as 8-11%. Depressed adolescents are also at…
On March 31, 2013, the Chinese health authorities announced the first human case of a new strain of avian influenza…