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Jan 22, 2025 | 
jdsupra.com | Shoshana Golden |Dan Jasnow |Wayne Matelski
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Jan 21, 2025 | 
afslaw.com | Dan Jasnow |Wayne Matelski |Shoshana Golden
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.
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Dec 6, 2023 | 
jdsupra.com | Wayne Matelski
A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or immunogenicity rates of the two drugs.
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Dec 5, 2023 | 
natlawreview.com | Wayne Matelski
A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or immunogenicity rates of the two drugs.
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Dec 5, 2023 | 
afslaw.com | Wayne Matelski
Off The research was conducted by the US Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars and the Division of Biometrics VIII of the Office of Biostatics, both within the Center for Drug Evaluation and Research (CDER). It was published in the October 3, 2023, issue of PLOS One. Biosimilars are increasingly available for the treatment of many serious diseases and disorders.
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Oct 30, 2023 | 
jdsupra.com | Wayne Matelski |Kevin Pinkney |Stephanie Trunk
One of the “pay fors” buried in a COVID-19 stimulus bill — the American Rescue Plan of 2021 — was the removal of the Average Manufacturer Price (AMP) cap on Medicaid Drug Rebate Program (MDRP) rebates. Manufacturers that desire for their covered outpatient drugs to be covered and paid by state Medicaid program must agree to participation in the MDRP and pay rebates on state Medicaid beneficiary utilization of their products.
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Oct 30, 2023 | 
afslaw.com | Stephanie Trunk |Wayne Matelski |Kevin Pinkney |Brian Waldman
Off One of the “pay fors” buried in a COVID-19 stimulus bill — the American Rescue Plan of 2021 — was the removal of the Average Manufacturer Price (AMP) cap on Medicaid Drug Rebate Program (MDRP) rebates. Manufacturers that desire for their covered outpatient drugs to be covered and paid by state Medicaid program must agree to participation in the MDRP and pay rebates on state Medicaid beneficiary utilization of their products.
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Oct 25, 2023 | 
jdsupra.com | Jack Bierig |Shoshana Golden |Wayne Matelski
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to provide that laboratory developed tests (LDTs) are medical devices under the federal Food, Drug, and Cosmetic Act (FDCA) and are subject to all accompanying regulations.
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Oct 24, 2023 | 
afslaw.com | Jack Bierig |Shoshana Golden |Wayne Matelski
LDTs, often informally referred to as “home brews,” are in vitro diagnostic tests developed and used within a single laboratory. These tests are generally not sold to other laboratories. Rather, health care providers send a specimen to a laboratory where an LDT is utilized to help reach and provide a diagnosis. Prior to the proposed regulation, the FDA had adopted a policy of enforcement discretion.
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Oct 18, 2023 | 
natlawreview.com | Wayne Matelski
The US Food and Drug Administration (FDA) issued yesterday new guidance on its enforcement policy covering face masks and barrier face coverings. Since the outbreak of the COVID-19 pandemic, the FDA has issued a series of guidances outlining its evolving views on which face masks and barrier coverings can be sold in the United States.
