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Establishing a quality culture ensures a safe and effective product, and saves costs.
Data may be used to improve (or remove) a corrective action/preventive action.
Testing various tablet-splitting devices showed how well they performed.
June 27, 2022
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NICE has published its final draft guidance recommending the use of Vazkepa (icosapent ethyl) in adults to reduce heart attacks and strokes.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The new draft guidance describes a standards recognition program for regenerative medicine therapies.
June 10, 2022
In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.