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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.
June 20, 2019
The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.
June 19, 2019
The agency is adding data points to its Paragraph IV Patent Certifications List, which provides brand exclusivity information, in order to help generic-drug applicants determine if their product can be approved and marketed.
The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.
June 18, 2019
Congress is weighing in on drug pricing with a range of measures that differ in style and substance.
June 13, 2019
Vida International received an FDA warning letter after an inspection found quality control violations.
June 11, 2019
The two countries have been included into the mutual recognition agreement between the European Union and the US FDA that recognizes facility inspections conducted in different territories.
June 10, 2019
Kingston Pharma LLC received a warning letter after an FDA inspection found violations of current good manufacturing practices including inadequate quality control.
June 07, 2019
Two facilities owned by Pharmasol Corporation were cited for violations of current good manufacturing practices in a FDA warning letter.
June 05, 2019
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
June 04, 2019
Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.