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June 22, 2021
FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.
June 21, 2021
The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
June 14, 2021
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.
June 11, 2021
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
June 08, 2021
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
June 07, 2021
The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.
June 02, 2021
International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.