Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

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

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

FDA Approves Novel Demodex Blepharitis Treatment

July 27, 2023

Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

Update on Storm Damage to Pfizer Facility in North Carolina

July 25, 2023

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

EMA Extends OPEN Framework to More Medicines

July 24, 2023

The framework is now expanded beyond COVID-19 vaccines and treatments.

EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine

July 24, 2023

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

EU Takes Steps to Prevent Antibiotic Shortages Next Winter

July 20, 2023

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products

July 20, 2023

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers

July 20, 2023

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

FDA Approves First Nonprescription Daily Oral Contraceptive

July 13, 2023

Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.

FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval

July 13, 2023

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk

July 13, 2023

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.