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…
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Risk-based Monitoring: Moving Forward
After issuance of the final guidance document by FDA on Oversight of Clinical Investigations – A Risk-based Approach to Monitoring,…
Regulation for Paediatric Drug Development in India: Need of the Hour
India is a popular location for clinical research due to the multitude of benefits it offers, including a large patient…
Our Love/Hate Relationship with Clinical Surveillance, and Why Both are Valid
CNS researchers have implemented surveillance strategies from within pharmaceutical companies, through contract research organizations, or by using one of the…
An Overview of the Legislative Framework for FDA Expedited Programs for Serious Conditions
On June 26, 2013, the US Food and Drug Administration (FDA) announced in the Federal Register, the publication of a…
Macroeconomic Forces Driving Clinical Trial Costs
A lot has been written about the Affordable Care Act (ACA) recently. Key provisions are kicking in over the next…
Pediatric Patient Retention: It’s not Child’s Play
In June 2013, the European Commission published a report on the first five years of the Paediatric Regulation that came…
The Role of Central Laboratories in AD Trials
Alzheimer’s disease (AD) is a debilitating neurodegenerative disorder that mainly affects the elderly population. The prevalence of AD is predicted…
Adjunctive Treatment with Atypical Antipsychotics Among Adolescents with Major Depressive Disorder
Among adolescents, lifetime prevalence estimates for major depressive disorder (MDD) range as high as 8-11%. Depressed adolescents are also at…
H7N9 Influenza and the Rush to Vaccine Development
On March 31, 2013, the Chinese health authorities announced the first human case of a new strain of avian influenza…