Quality Systems
Keynote Session Highlights Importance of Process Validation and Data Integrity (INTERPHEX 2024)
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.
FDA Establishes Center for Clinical Trial Innovation
April 15, 2024
C3TI will promote CDER’s clinical trial innovation activities both internally and externally.
EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies
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.
FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
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The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug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.
Europa Perspectives on Lifecycle Management
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.
FDA Approves New Antibiotic to Treat Three Different Bacterial Infections
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.
FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments
April 04, 2024
The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.
Steps Towards Demystifying Risk-Based Decision Making
April 03, 2024
It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Making Lifecycle Management More Efficient in Europe
April 02, 2024
Plans to update the European Union’s variation framework have been finalized.
Looking at the Potential Impact of JCA on Pharma
April 02, 2024
The European pharma industry needs to be prepared for the new clinical data requirements.