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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.
July 08, 2022
Some states look to block access to approved drugs.
LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.
July 02, 2022
By understanding potential material change, the impact on patient safety can be understood and mitigated.
A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.
June 30, 2022
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
June 29, 2022
The European Commission has approved Cosentyx for the treatment of various childhood arthritic conditions.
The European Commission has approved Xenpozyme as the first treatment for ASMD.
The action plan will span over five years and will fulfill a requirement of the Accelerating Access to Critical Therapies for ALS Act.