April 17, 2024
Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.
April 15, 2024
C3TI will promote CDER’s clinical trial innovation activities both internally and externally.
April 12, 2024
The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.
April 11, 2024
The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.
April 09, 2024
In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.
April 05, 2024
Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.
April 04, 2024
The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.
April 03, 2024
It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
April 02, 2024
Plans to update the European Union’s variation framework have been finalized.
April 02, 2024
The European pharma industry needs to be prepared for the new clinical data requirements.