Bracken’s collective drug and product regulatory experience helps companies avoid costly delays and unnecessary investor and partner risk. Our experts help development teams from initial filing through regulatory approval.
In September 2018, the FDA released a draft guidance which proposed civil money penalties for non-compliance with the submission of clinical trial results for the inclusion in ClinicalTrials.gov.
Bracken responded to the draft guidance, giving their perspective on the proposed penalties and how clinical trial sponsors can ensure compliance with these requirements.
We have extensive experience in guiding development teams and investors from initial filing through regulatory approval.
We would be delighted to hear from you and discuss our consulting services. Please call +1 215 648 1208 to chat with us directly. Or write to us using the form provided here. We look forward to collaborating with you.