Annals of Family Medicine

NOVEMBER 20, 2024

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.

Vaccination 130

Vaccination Family Medicine DO Primary Care 130

FDA Law Blog

JUNE 7, 2021

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). Yesterday’s approval of Aduhelm helped answer that.

Clinic 98

Clinic IT Private Practice Utilities 98

FDA Law Blog

AUGUST 21, 2023

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.) 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.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

SEPTEMBER 14, 2021

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. For drugs approved before July 1, 2015, the baseline quarter is 1Q 2016, and for drugs approved after that date, the baseline quarter is the third full quarter after launch.

Manufacturing 52

Manufacturing Insurance Government Patients 52