FDA seeks “creative” solutions to clear up the regulatory ambiguities associated with continuous manufacturing. Agency also notes “teething problems” with continuous manufacturing implementation.
FDA officials explained that a different control strategy is needed to demonstrate drug quality for solid oral drugs made by continuous mode than batch mode, reflecting the very different nature of these manufacturing processes.
FDA is attempting to clear up some of the ambiguities associated with continuous manufacturing, and this pronouncement reflects the agency’s...
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
