Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring…
The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Source: Drug…
Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected…
China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021. Source: Drug Industry Daily
Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Source:…
Australia’s Therapeutics Goods Agency (TGA) has issued a new paper on its plan to establish a unique device identification (UDI) system and it wants to hear reactions from device sponsors.…
The FDA has updated its electronic medical device reporting (eMDR) system to include new fields for summary reports and combination products to harmonize with international reporting codes. Source: The GMP…
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with…
In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those…
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for…