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).

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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. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Vaccination IT Manufacturing Screening 64

Family Medicine Initiative

APRIL 10, 2024

million people in 2018), shows that the longer you know your GP, the better off you are. On average, twice as many patients have contact with GPs than with all specialists (in offices and/or outpatient clinics) combined. of healthcare costs in the EU 2018. A fantastic study from Norway 12 (based on 4.5

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Family Physician Family Families GP 130

PEMBlog

DECEMBER 4, 2024

In this episode of PEM Currents: The Pediatric Emergency Medicine Podcast , we explore pertussis, also known as whooping cough – a disease that remains a public health challenge despite widespread vaccination efforts. Pediatr Rev May 2018; 39 (5): 247–257. Daniels, Camille Sabella; Bordetella pertussis (Pertussis).

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IT Vaccination Diagnosis Complication 52

PEMBlog

MAY 9, 2024

Common variants associated with general and MMR vaccine-related febrile seizures. 2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Vaccines don’t cause autism, but they might cause febrile seizures. The absolute risk is small, and genetic susceptibility likely plays a role in seizures after vaccines. Pediatrics.

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Illness Vaccination Families Family 59