By Kate Rawson
The Food & Drug Administration thinks it is winning converts for its vision of personalized medicine.
There's no question the pharmaceutical industry is desperate for a more efficient R&D machine, and FDA thinks it has one answer: personalized medicine. But for Big Pharma, the idea runs counter to the commercial reality: no one has yet demonstrated a viable model for making personalized medicine pay off. Knowing where and how to invest in personalized medicine--and taking advantage of FDA's interest the area--will increase the chances of commercial success.
By Kate Rawson
The Food & Drug Administration thinks it is winning converts for its vision of personalized medicine.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.