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Apr 5, 2024 | 
morganlewis.com | Kathleen M. Sanzo |Stephanie Feingold |Alexandre Gapihan |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) recently announced that manufacturers have completed the voluntarily phase-out of the use of certain per- and polyfluoroalkyl substances (PFAS) in grease-proofing agents for food packaging. PFAS consist of a large group of synthetic chemicals that have been used widely in consumer products and industrial processes since the 1950s for a broad range of uses, including to keep food from sticking to cookware or packaging, or make clothes resistant to stains.
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Mar 6, 2024 | 
jdsupra.com | Alexandre Gapihan |Maria Kalousi-Tatum |Kathleen M. Sanzo
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
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Mar 5, 2024 | 
morganlewis.com | Kathleen M. Sanzo |Alexandre Gapihan |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements. In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension).
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Feb 12, 2024 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo |Maria Kalousi-Tatum
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs).
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Feb 9, 2024 | 
morganlewis.com | Dennis Gucciardo |Michele L. Buenafe |Maria Kalousi-Tatum
The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health recently announced its intention to reclassify certain high-risk in vitro diagnostic devices (IVDs) as moderate risk, a potential first step as the agency prepares to oversee laboratory-developed tests (LDTs).
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Dec 11, 2023 | 
jdsupra.com | Michele L. Buenafe |Dennis Gucciardo |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory.” The proposed rule also includes an up to four-year phase-out policy of enforcement discretion historically provided to LDTs from compliance...
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Dec 8, 2023 | 
morganlewis.com | Dennis Gucciardo |Michele L. Buenafe |Maria Kalousi-Tatum
The US Food and Drug Administration (FDA) received thousands of comments on its recently proposed rule that would make clear the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices by adding 10 words to the definition of in vitro diagnostic products (IVDs): “including when the manufacturer of these products is a laboratory.” The proposed rule also includes an up to four-year phase-out policy of enforcement discretion historically provided to LDTs from compliance...
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May 10, 2023 | 
lexology.com | Scott Memmott |Howard Young |Jacob Harper |Michele L. Buenafe |Gregory Etzel |Dennis Gucciardo | +12 more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of Health and Human Services (HHS) on January 31, 2020, and subsequently renewed several times, provided the basis for numerous flexibilities upon which the healthcare and life sciences industries have relied to furnish patient care during the pandemic.
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Apr 14, 2023 | 
morganlewis.com | Michele L. Buenafe |Dennis Gucciardo |Maria Kalousi-Tatum |Angela Silva |Ângela Silva
The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing authorization.
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Apr 14, 2023 | 
lexology.com | Michele L. Buenafe |Dennis Gucciardo |Maria Kalousi-Tatum |Angela Silva |Ângela Silva
The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing authorization.
