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November 03, 2016
FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
November 02, 2016
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
October 26, 2016
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
October 19, 2016
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
October 18, 2016
The guidance assists applicants in preparing prior approval supplements for abbreviated new drug applications.
October 13, 2016
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
October 10, 2016
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
October 03, 2016
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.
he guidance addresses the good manufacturing practice for managing quality in APIs.