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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.
January 12, 2022
The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).
January 10, 2022
FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).
January 07, 2022
FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.
FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.
Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.
January 05, 2022
FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.
Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.
Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.
Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.
January 03, 2022
The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.