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July 01, 2020
As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry.
June 30, 2020
The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.
June 26, 2020
FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.
June 25, 2020
Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.
Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.
The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
June 23, 2020
Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
June 22, 2020
The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.
June 19, 2020
The products are being recalled because of missing graduation marks on the dosing cups