OR WAIT null SECS
January 12, 2023
WHO in midst of forming group focused on developing guidance on best practices in clinical trials.
January 09, 2023
House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.
January 03, 2023
With compliance deadline at end of month, concerns over readiness remain.
December 22, 2022
Despite agreement on recommendations between European regulators, DCT unclarity remains.
The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.
December 15, 2022
Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.
December 14, 2022
Insights from second annual DTRA meeting indicate DCTs are here to stay.
December 06, 2022
Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.
December 02, 2022
A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.
Summarizing important FDA and EMA revisions issued this year.