Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

Executive Summary

A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.

You may also be interested in...



TrialScope Anticipates FDA Will Begin Inspecting Companies For Trial-Reporting Compliance

US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties  and it looks like SMEs will be hardest hit.

Clinical Trial Sponsors Take Heed: Study Disclosure Rules Are Expanding

The recent update of Title VIII of the Food and Drug Administration Amendments Act of 2007 clarifies the requirements for registering clinical trials and disclosing  trial results to US FDA, but many trial sponsors and investigators are still confused about their obligations under these rules, as well as the rules governing clinical trial registration and disclosure abroad. Francine Lane, the VP of global transparency at TrialScope, talked to Medtech Insight about the challenges facing clinical trial sponsors trying to comply with these rules and offered some predictions about how these regulations will likely evolve in the future.

Becton Dickinson, BioMedomics Collaborate On Rapid Serology COVID-19 Test

BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.

Topics

UsernamePublicRestriction

Register

MT123305

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel