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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 04, 2020
The agency is advising healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine for potential side effects.
The agency sent a warning letter to Chloroquineonline.com for selling unapproved products for the treatment of COVID-19.
June 03, 2020
Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.
June 02, 2020
FDA and the US Congress support innovation and access to cheaper medicines.
Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.
May 26, 2020
The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.
May 21, 2020
The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.