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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

It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit). So how did we get here?

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. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)