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1 month ago | 
jdsupra.com | Emily Cook |James Ravitz
In April, McDermott gathered more than 100 health and life sciences innovators, investors, business leaders and advisers in Paris for our annual European Health & Life Sciences symposium. With such an esteemed crowd available to share insights and expertise, we took the opportunity to consider some of the more recent developments in US government policy and how political shifts on healthcare policy might impact the sector in the years to come.
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Mar 6, 2025 | 
lexology.com | James Ravitz |Paul S. Gadiock |Marshall Jackson |Patrick Zanayed |Lisa S. Mazur |Jae Lee
On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug.
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Feb 21, 2025 | 
lexology.com | James Ravitz |Paul S. Gadiock |Michael Ryan |Jeff Weinstein |Marissa Daley |Karis Jackson | +2 more
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however.
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Feb 19, 2025 | 
jdsupra.com | Paul S. Gadiock |James Ravitz |Jeff Weinstein
Overview On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance finalizes FDA’s revised draft guidance issued in October 2023 concerning firm-initiated communications of scientific information on unapproved uses (SIUU) of approved or cleared medical products to healthcare...
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Jan 13, 2025 | 
today.westlaw.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley
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Jan 10, 2025 | 
mondaq.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley
On December 19, 2024, the US Food and Drug Administration (FDA)issued a new final rule titled "Food Labeling: Nutrient Content Claims; Definitionof Term 'Healthy.'" The rule revises regulationsthat govern when food products may be labeled as"healthy" and when a derivative term (e.g.,"health," "healthful," or"healthier") may be used to make a claim about theproduct's nutritional content.
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Oct 11, 2024 | 
natlawreview.com | James Ravitz
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug. An end to the shortage has important implications for industry stakeholders at various points in the medication’s supply chain. Compounding pharmacies and providers should be aware of the impact this change in shortage status has on their operations.
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Oct 11, 2024 | 
natlawreview.com | James Ravitz
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list.
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Oct 9, 2024 | 
lexology.com | James Ravitz |Paul S. Gadiock |Marshall Jackson |Lisa S. Mazur |Patrick Zanayed |Paul Hughes | +1 more
On October 3, 2024, the US Food and Drug Administration (FDA) revised its shortage categorization of tirzepatide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the drug. An end to the shortage has important implications for industry stakeholders at various points in the medication’s supply chain. Compounding pharmacies and providers should be aware of the impact this change in shortage status has on their operations.
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Sep 9, 2024 | 
mondaq.com | James Ravitz |Paul S. Gadiock |Marissa Daley
On August 8, 2024, the US Food and Drug Administration (FDA)
partially revised the availability of certain glucagon-like peptide
1 (GLP-1) medications on the FDA's shortage list.
