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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 16, 2020
The International Coalition of Medicines Regulatory Authorities met again on June 12 to discuss policy approaches to the COVID-19 pandemic.
The report highlights agency’s accomplishments in 2019, including its relocation to Amsterdam.
June 15, 2020
Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.
June 11, 2020
Will efforts to limit all returns on investment drive biopharma companies away from developing much-needed interventions for COVID-19.
June 09, 2020
The 120-day pilot program was set up to help reduce the availability of unapproved opioids illegally offered for sale online.
The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.
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.