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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.
March 26, 2019
The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.
March 25, 2019
The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.
March 22, 2019
Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.
Sartorius introduced the Cubis II portfolio of laboratory balances at Pittcon 2019 in Philaphelia, PA.
March 20, 2019
The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.
The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.
March 19, 2019
The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.
March 18, 2019
The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.
March 15, 2019
The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.