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Jun 5, 2024 | 
pharmaceuticalcommerce.com | Anil Shankar |Adria Warren |Jordan Smiley
June 5, 2024The courts reversed certain key guidance documents issued by the Health Resources and Services Administration for the 340B Program, which raises uncertainty. The 340B Drug Pricing Program continued to evolve in 2023, and further changes may be forthcoming as a result of ongoing lawsuits and regulatory action.
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Apr 5, 2024 | 
today.westlaw.com | Jordan Smiley |Kyle Faget
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Apr 4, 2024 | 
mondaq.com | Jordan Smiley |Kyle Faget
The U.S. Food and Drug Administration (FDA) has recently issued
guidance for sponsors and investigators interested in submitting a
non-interventional study, commonly known as an observational study,
to contribute evidence of a drug's safety and effectiveness. These drug studies aim to distinguish the drug's effects from
other factors like disease progression, placebo responses, or
observer bias.
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Apr 2, 2024 | 
jdsupra.com | Kyle Faget |Jordan Smiley
The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, to contribute evidence of a drug’s safety and effectiveness. These drug studies aim to distinguish the drug’s effects from other factors like disease progression, placebo responses, or observer bias.
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Apr 1, 2024 | 
mondaq.com | Adam J. Hepworth |Anil Shankar |Jordan Smiley
Leading health authorities have increasingly emphasized how
non-medical factors such as socioeconomic status, education,
employment, housing, food security, and community support have an
outsized impact on health outcomes. By some recent U.S. estimates, clinical care
accounts for only 20% of county-level variation of health outcomes
in the United States, with the social determinants of health (SDOH)
responsible for as much as 50%.
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Mar 28, 2024 | 
jdsupra.com | Adam J. Hepworth |Anil Shankar |Jordan Smiley
Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By some recent U.S. estimates, clinical care accounts for only 20% of county-level variation of health outcomes in the United States, with the social determinants of health (SDOH) responsible for as much as 50%.
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Mar 15, 2024 | 
jdsupra.com | Kyle Faget |Jordan Smiley
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical investigations of medical products and Department of Health and Human Services (HHS) supported human subjects research. The Guidance aims to assist sponsors, investigators, and institutional review boards (stakeholders) involved in or tasked with overseeing human subject research.
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Mar 14, 2024 | 
natlawreview.com | Jordan Smiley
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical investigations of medical products and Department of Health and Human Services (HHS) supported human subjects research. The Guidance aims to assist sponsors, investigators, and institutional review boards (stakeholders) involved in or tasked with overseeing human subject research.
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Dec 13, 2023 | 
mondaq.com | Kyle Faget |Jordan Smiley
In November 2023, the U.S. Food and Drug Administration (FDA)
published its final rule (Rule)1 to amend its regulations concerning
radio and television direct-to-consumer (DTC) advertisements (ads)
for human prescription drugs by firms, which includes
manufacturers, packers, and distributors of prescription drugs and
all of their representatives, including both individuals and
corporate entities (Prescription Drug Firms).
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Dec 7, 2023 | 
jdsupra.com | Kyle Faget |Jordan Smiley
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule)[1] to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs by firms, which includes manufacturers, packers, and distributors of prescription drugs and all of their representatives, including both individuals and corporate entities (Prescription Drug Firms).
