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Wait Times: Direct Primary Care vs. Traditional Primary Care

The Direct Doctors Difference

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’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. From PPE to diagnostics, treatments to vaccines, the review staff have been applying a new statutory standard: that which supports Emergency Use Authorization (EUA) of a product for COVID. First, it was noteworthy what was missing from the label.

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Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?

FDA Law Blog

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.

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

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.

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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog

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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Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

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.

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Going beyond the surface material: A podcast episode on cellulitis

PEMBlog

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. And so a lot of the previous studies on getting blood cultures were done in the immediate post Haemophilus influenzae B and Prevnar vaccine era.

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