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
2/9/2022
/ Clinical Trials ,
Data Privacy ,
Deadlines ,
Disclosure Requirements ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Life Sciences ,
Member State ,
New Regulations ,
Proposed Regulation ,
Reporting Requirements ,
UK
Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence
Last month the Department of Education (“DOE” or “Department”) released an...more
11/23/2020
/ Accounting Controls ,
Audits ,
Compliance ,
Department of Defense (DOD) ,
Department of Education ,
Department of Energy (DOE) ,
Department of Justice (DOJ) ,
Educational Institutions ,
False Claims Act (FCA) ,
FBI ,
Foreign Entities ,
Higher Education Act ,
NASA ,
National Institute of Health (NIH) ,
National Security ,
Proposed Legislation ,
Reporting Requirements
FDA issued a Form FDA 483 to fifteen prominent hospitals across the United States following inspections that demonstrated failures to comply with the user facility medical device reporting requirements pursuant to 21 C.F.R....more