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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.
November 01, 2016
US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.
October 27, 2016
Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.
October 26, 2016
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
October 24, 2016
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
October 20, 2016
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
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.
The agency recommended granting conditional marketing authorization of Ocaliva for the treatment of primary biliary cholangitis.
The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.