A Milestone Moment For Pharmacogenomics: US FDA Ready To Drop ‘Voluntary’ Program
The US FDA’s plan to update a 20-year-old guidance on pharmacogenomic data submissions is a good time to reflect on the dramatic transformation of industry attitudes and approaches to targeted medicine over the past two decades.
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From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age At FDA
An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.
Getting Personal: FDA's Plan to Save the Drug Industry
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.
The Power Of The Open Public Hearing
The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.