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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 09, 2020
The agency has added a COVID-19 innovation resource page and an education resources page to its website.
June 08, 2020
The European Commission is pledging EUR 300 million (US$339 million) to Gavi for vaccines for infectious diseases, in addition to an earlier pledge of more than EUR 1.5 billion (US$1.7 billion) made on May 4, 2020.
June 05, 2020
Johnson & Johnson’s Janssen Pharmaceutical Companies has received a positive opinion in Europe for its two-dose Ebola vaccine regimen.
June 04, 2020
The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.
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.