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...
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...
According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities. The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all...
In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...
The FDA released two new documents aimed to clarify the process for clinical trial approval and establishing earlier clinical trial studies during device development. The FDA is currently searching for a small number of companies to in the pilot program. Jeffery...
