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HPV Vaccine Secondary Acceptance: Turning No into a Yes! [Child and adolescent health]

Annals of Family Medicine

Context: The human papillomavirus (HPV) vaccine is recommended starting at age 9 to reduce risk of HPV linked squamous cell cancers, yet recent data shows that only 58.6% have been vaccinated by age 17. Secondary acceptance is agreeing to a vaccine subsequent to declining in a previous encounter. Child (e.g.,

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FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

As an aside, we have found this inconsistency between which accelerated approval therapies are saddled with this sentence to be a paradoxical FDA policy as there is but a single standard for surrogate endpoints to be utilized for purposes of every Accelerated Approval (i.e., be “reasonably likely to predict” ultimate clinical benefit).

Clinic 98
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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.