OR WAIT null SECS
It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
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.
May 02, 2019
The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.
This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
May 01, 2019
The company is voluntarily recalling the product due to difficulties with the delivery system.
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.
A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.
April 26, 2019
Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.
April 18, 2019
CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.
The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.