USA – FDA releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
USA – FDA expands bivalent COVID boosters to kids as young as 5
The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand...
USA – Experts call for federal incentives to promote clinical trial diversity
A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of...
USA – Sentinel System expands capacity, data linkages, report indicates
The US Food and Drug Administration’s Sentinel System, which monitors the safety of approved medical products, has expanded its capacity to support regulatory decisions...
USA – FDA updates guidances to clarify new generic drug meeting requirements in GDUFA...
The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments...
USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA...
The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User...
USA – FDA offers details on PDUFA VII STAR review pilot
The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten...
USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each...
USA – OIG raises concerns about accelerated approval pathway
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
