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Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”
FreeTrials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).
C. David Allis, pioneer of chromatin biology and epigenetics, dies at 71
FreeObituary

C. David Allis, pioneer of chromatin biology and epigenetics, dies at 71

When you hear the words “world famous scientist,” “devoted parent and husband,” “enthusiastic mentor,” and “committed friend,” who comes to mind?  I, like many others across the world, think of Dr. C. David Allis. David, a prolific scientist, with over 400 publications and more than 100,000 citations, made many discoveries that have shaped our understanding about how genes are regulated and made a full circle bench-to-bedside impact.