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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.
July 26, 2022
Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.
July 25, 2022
The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
July 20, 2022
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
July 18, 2022
Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.
The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.
July 15, 2022
Exhibitors display innovations for parenteral and solid dose products.
July 14, 2022
Application for OTC contraceptive highlights efforts to broaden access to medicines.