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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.
April 22, 2020
The company is recalling the product because of out-of-specification results for high molecular weight polymers.
The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.
With hundreds of clinical trials for potential coronavirus therapies in the works concerns have mounted about the emergence of conflicting data, useless results, and wasted efforts from multiple overlapping efforts.
April 17, 2020
The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.
April 16, 2020
The guidance document describes the agency’s temporary policy for the compounding of drugs during the COVID-19 pandemic.
The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination.
Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.
April 15, 2020
The agency sent warning letters to three more companies for selling unapproved products claiming to treat COVID-19.
April 13, 2020
Drug manufacturers, distributors, and dispensers oppose Buy American policies as likely to reduce reliable supplies and raise product costs.
April 10, 2020
The task force will assist in the developing, authorizing, and monitoring of treatments of COVID-19.