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, 2016
The author looks at EUCAST’s role in tackling the spread of antimicrobial resistance, by creating definitions for a global consensus.
April 29, 2016
The agency found no differences in risk of pneumonia for different products.
The agency extends the indication of the drug in combination with bendamustine.
The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.
Platinum Press provides serialization-ready printed materials to apply final track-and-trace data onto packaged pharmaceutical products.
Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.
April 28, 2016
The agency holds a workshop to strengthen collaboration with healthcare providers.
April 27, 2016
The company voluntarily recalls product due to particulate matter.
April 25, 2016
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
Instruments are introduced for elemental impurity analysis and materials identification.