Topic

Feliza Mirasol is the science editor for 

Articles

Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.

Keynote Session Highlights Importance of Process Validation and Data Integrity (INTERPHEX 2024)

C3TI will promote CDER’s clinical trial innovation activities both internally and externally.

FDA Establishes Center for Clinical Trial Innovation

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.

EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Videos

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.

Europa Perspectives on Lifecycle Management

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 Approves New Antibiotic to Treat Three Different Bacterial Infections

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments

Valerie Mulholland is a PhD Candidate, Pharmaceutical Regulatory Science Team (PRST), Technological University Dublin.

Anne Greene, PhD, is director PRST, Technological University Dublin.

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Plans to update the European Union’s variation framework have been finalized.

Making Lifecycle Management More Efficient in Europe

Cheryl Barton is director of PharmaVision, 

The European pharma industry needs to be prepared for the new clinical data requirements.

Quality Systems