The Food and Drug Administration has made the decision to effectuate two provisions of the user fee law in hopes to amplify the voice of the patient in the process of drug development. This action will surely be celebrated by many patient groups and disease advocacy...
While there are many different size clinical research sites, competition becomes increasingly difficult for smaller sites with smaller amounts of employees, resources, etc.. In a recent article written by Gina Nesbit, a hypothetical site is created, Acme Research,...
Although the elderly are often considered ineligible for clinical trials, experts in a recent article from Outsourcing-pharma.com are saying the age group “must be taken into consideration more often during research.” Clinical trials are intended to be...
Effective September 26,2012 Health and Human Services has assigned responsibility to FDA for enforcing reporting by sponsors on ClinicalTrials.gov. Based on a notice by the Federal Register, FDA is now responsible for keeping track of the database’s most recent...
TransCelerate BioPharma which is an intriguing new big pharma collaboration was recently launched at a US trade show with the intentions of expediting the clinical research process. According to a recent article from Outsourcing-pharma.com , there are “five...
