News & Analysis as of

Life Sciences › Reporting Requirements › Clinical Trials

Health Care Compliance Association (HCCA)

In This Month’s E-News: September 2024

Health Care Compliance Association (HCCA) on

Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

Butler Snow LLP on

From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Hogan Lovells

OIG audit finds lack of compliance with ClinicalTrials.gov reporting requirements from NIH studies

Hogan Lovells on

A newly released audit by the Office of Inspector General (OIG) found that for clinical trials funded by the National Institutes of Health (NIH) for which responsible parties were required to submit results to...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

King & Spalding on

Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

Hogan Lovells on

On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

American Conference Institute (ACI)

[Event] FDA BOOT CAMP - March 25 - 27, 2019, New York, NY

American Conference Institute (ACI) on

Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more

6 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide