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The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
Vincent J Roth Esq
Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq
Vincent J Roth Esq
Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Vincent J Roth Esq
Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq
Vincent J Roth Esq
Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …