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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.
June 27, 2022
Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.
The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
June 22, 2022
FDA is at a pivotal moment because of important gains in medical treatment based on science.
June 21, 2022
The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.
Lessons learned from the COVID-19 pandemic about the benefits of international collaboration were discussed in a May 2022 workshop.
June 17, 2022
Measure tackles infant formula, cosmetics, diagnostics plus drug development and access.
MHRA has been accepted as a full member of three international work-sharing partnerships aimed at making sure medicines and medical devices are regulated safely and efficiently across the world.
NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.
June 16, 2022
The draft ICH Q9(R1) document details the importance of quality risk management principles.
The new draft guidance describes a standards recognition program for regenerative medicine therapies.