The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
07/25/24 • 34 min
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?
On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.
Visit our site for more information and related resources: https://www.ebglaw.com/dhc79
Subscribe for email notifications: https://www.ebglaw.com/subscribe.
Visit: http://diagnosinghealthcare.com.
This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?
On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.
Visit our site for more information and related resources: https://www.ebglaw.com/dhc79
Subscribe for email notifications: https://www.ebglaw.com/subscribe.
Visit: http://diagnosinghealthcare.com.
This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Visit our site for more information and related resources: https://www.ebglaw.com/dhc78
Subscribe for email notifications: https://www.ebglaw.com/subscribe.
Visit: http://diagnosinghealthcare.com.
This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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Visit our site for more information and related resources: https://www.ebglaw.com/dhc80
Subscribe for email notifications: https://www.ebglaw.com/subscribe.
Visit: http://diagnosinghealthcare.com.
This podcast is presented by Epstein Becker & Green, P.C. All rights are reserved. This audio recording includes information about legal issues and legal developments. Such materials are for informational purposes only and may not reflect the most current legal developments. These informational materials are not intended, and should not be taken, as legal advice on any particular set of facts or circumstances, and these materials are not a substitute for the advice of competent counsel. The content reflects the personal views and opinions of the participants. No attorney-client relationship has been created by this audio recording. This audio recording may be considered attorney advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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