FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
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...
Check out this article which discusses some strategies to better communicate with regulatory agencies in the preclinical stage of drug approval. Some of the major themes highlighted are to stay consistent and accurate when discussing your product, think twice about...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
