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. Child (e.g.,

Vaccination 130

Vaccination Family Medicine DO Primary Care 130

FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). be “reasonably likely to predict” ultimate clinical benefit).

Clinic 98

Clinic IT Private Practice Utilities 98

FDA Law Blog

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. The omitted phrase therefore provided material facts that may be relevant to prescribing veterinarians and dog owners. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

Vaccination 64

Vaccination IT Manufacturing Screening 64