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November 02, 2021
Different methods give different answers when calculating limits for impurities. The prediction interval method may be the best option.
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.
October 15, 2021
Knowledge management has gained increasing importance in the pharmaceutical industry over the past 10–15 years
October 03, 2021
Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.
October 02, 2021
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
September 29, 2021
GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.
September 23, 2021
Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.
September 21, 2021
US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.
September 03, 2021
As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.