FDA Law Blog
JUNE 7, 2021
Subpart H) pathway in 2014, then issued it as final guidance in January 2019. Valentine — Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. What do we mean?
The Direct Doctors Difference
OCTOBER 21, 2021
As an update to that blog , we want to begin by highlighting again that according to Merritt Hawkins, the average wait time for a new patient appointment with a primary care doctor is 29 days, up 50% from 2014. In Rhode Island, the wait continues to be much longer. What does this mean for primary care (and specialist offices for that matter)?
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FDA Law Blog
JANUARY 7, 2024
To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.
FDA Law Blog
FEBRUARY 4, 2025
The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies. Below, we discuss some of its downstream impacts on the PRV landscape.
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.
BMJ
AUGUST 20, 2021
We sought to analyse how prescribing trends have changed over time, utilising a dataset containing all prescriptions signed and dispensed in the UK by primary care facilities from January 2014 to November 2020.
PEMBlog
JANUARY 17, 2024
Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis 2014; 59:e10. This episode will help you recognize cellulitis and even differentiate it from erysipelas which is totally a different thing. Clin Infect Dis 2011; 52:e18.
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