On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Biogen, Inc.'s Aduhelm (aducanumab) to treat Alzheimer's disease through the FDA Accelerated Approval Program in a landmark decision. The FDA's approval...more
In Washington: President-elect Joe Biden picked California Attorney General Xavier Becerra to be his health secretary. Becerra was a defender of the Affordable Care Act. Separately, Biden picked a Harvard infectious...more
In Washington: Two Treasury Department moves in recent days are generating controversy among lawmakers and policymakers: Treasury Secretary Steven Mnuchin announced Thursday that he will not extend the Federal...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more
Last month, the FDA announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks...more
This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more