FDA Law

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. 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. What do we mean?

Clinic 98

Clinic IT Private Practice Utilities 98

FDA Law

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

BMJ

AUGUST 20, 2021

In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions. Over one billion prescriptions per year are signed in the UK by these general practitioners (GPs) in primary care.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

PEMBlog

MAY 9, 2024

Common variants associated with general and MMR vaccine-related febrile seizures. Nat Genet 2014; 46:1274. 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. So again, pretty darn low.

Illness 59

Illness Vaccination Families Family 59