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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 15, 2022
Exhibitors display innovations for parenteral and solid dose products.
July 14, 2022
Application for OTC contraceptive highlights efforts to broaden access to medicines.
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.