Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Senate Agriculture Committee Releases Draft Text For 2026 Farm Bill
The U.S. Senate Committee on Agriculture released its draft Farm Bill on June 23, 2026, proposing significant reforms across commodity programs, conservation initiatives, trade promotion, and rural development. Chair John Boozman plans to advance the legislation after the July recess, though Democratic support remains uncertain due to unaddressed concerns about SNAP program cuts from the One Big Beautiful Bill.
United States Healthcare
HK
Holland & Knight
Article
Federal Court Hands Major Win To Tissue Product Manufacturers – FDA’s HCT/P Classification Decision For Umbilical Cord–Derived Product CORDGRAFT Rejected
A federal court has overturned the FDA's classification of an umbilical cord-derived tissue product, ruling that the agency misapplied its own "minimal manipulation" standard by focusing solely on the tissue's function in the donor rather than its potential benefits to recipients. The decision could reshape the regulatory landscape for tissue banks, regenerative medicine companies, and HCT/P manufacturers by making it easier for structural tissue products to qualify for less burdensome Section 361 regulator
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
Article
California AG Notches Another CPOM Settlement
California's Attorney General has secured another enforcement settlement targeting MSO/PC structures in healthcare, requiring Carbon Health to restructure its friendly-PC model. The complaint alleges unusually direct control rights including MSO authority over physician hiring, exclusive financing arrangements, and operational decision-making that may violate the corporate practice of medicine doctrine. This action continues the AG's systematic campaign against management service organizations that exercise
United States Healthcare
KM
Katten Muchin Rosenman LLP
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Food and Drugs Law

Article
Building Strong Chemical Genus Claims In An Evolving § 112 Landscape
Broad chemical genus claims represent valuable pharmaceutical patent assets, yet face increasing judicial scrutiny under written description and enablement requirements. Recent Federal Circuit and Supreme Court decisions have reinforced that broader claims demand more robust supporting disclosures, requiring applicants to carefully consider specification strategies when seeking expansive chemical claim coverage.
United States IP
BB
Baker Botts LLP
Article
Practical Tips After U.S. Supreme Court’s Hikma v. Amarin Case
The Supreme Court's unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. fundamentally reshapes the legal landscape for generic drug manufacturers pursuing skinny-label strategies under Section viii carve-outs. By rejecting the Federal Circuit's reader-focused approach and requiring affirmative, purposeful conduct to establish induced infringement, the Court provides substantial new protections while leaving critical questions about implicit inducement and commercial communications pr
United States IP
UT
Upadhye Tang
Article
Senate Agriculture Committee Releases Draft Text For 2026 Farm Bill
The U.S. Senate Committee on Agriculture released its draft Farm Bill on June 23, 2026, proposing significant reforms across commodity programs, conservation initiatives, trade promotion, and rural development. Chair John Boozman plans to advance the legislation after the July recess, though Democratic support remains uncertain due to unaddressed concerns about SNAP program cuts from the One Big Beautiful Bill.
United States Healthcare
HK
Holland & Knight
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Life Sciences, Biotechnology & Nanotechnology

Article
Building Strong Chemical Genus Claims In An Evolving § 112 Landscape
Broad chemical genus claims represent valuable pharmaceutical patent assets, yet face increasing judicial scrutiny under written description and enablement requirements. Recent Federal Circuit and Supreme Court decisions have reinforced that broader claims demand more robust supporting disclosures, requiring applicants to carefully consider specification strategies when seeking expansive chemical claim coverage.
United States IP
BB
Baker Botts LLP
Article
Federal Court Hands Major Win To Tissue Product Manufacturers – FDA’s HCT/P Classification Decision For Umbilical Cord–Derived Product CORDGRAFT Rejected
A federal court has overturned the FDA's classification of an umbilical cord-derived tissue product, ruling that the agency misapplied its own "minimal manipulation" standard by focusing solely on the tissue's function in the donor rather than its potential benefits to recipients. The decision could reshape the regulatory landscape for tissue banks, regenerative medicine companies, and HCT/P manufacturers by making it easier for structural tissue products to qualify for less burdensome Section 361 regulator
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
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Healthcare

Article
FTC And 4 States Target Transgender Care Organization, Alleging False Advertising
The Federal Trade Commission has filed a groundbreaking lawsuit against the World Professional Association for Transgender Health, alleging the organization deceives families about gender-affirming care for minors to sustain a lucrative medical industry. This unprecedented enforcement action treats clinical medical guidelines themselves as false advertising, potentially opening a new frontier in consumer protection law with far-reaching implications for medical practice and First Amendment protections.
United States Consumer
FK
Frankfurt Kurnit Klein & Selz
Article
Arizona Joins The Growing Movement To Separate PBMs From Pharmacy Ownership
Arizona lawmakers have introduced legislation that could fundamentally reshape the pharmacy marketplace by prohibiting pharmacy benefit managers from owning retail pharmacies. The bill joins a growing national movement challenging vertical integration in healthcare, raising critical questions about market competition, patient access, and the future of independent pharmacies.
United States Government
BI
Buchanan Ingersoll & Rooney PC
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