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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
FDA’s Proposed GRAS Rule: Mandatory Notifications, Expanded Scope, And Open Questions
The FDA has proposed a rule that would fundamentally transform how food substances enter the U.S. market under the Generally Recognized as Safe (GRAS) framework, converting what has been a voluntary notification system into a mandatory disclosure requirement. Companies would be required to notify FDA of their GRAS conclusions before or shortly after introducing substances into interstate commerce, though the rule stops short of creating a premarket approval system. The proposal raises critical questions abo
United States Healthcare
KD
Kelley Drye & Warren LLP
Article
FDA Proposes Mandatory GRAS Notification Requirement
The U.S. Food and Drug Administration has proposed converting its voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement, fundamentally reshaping how food ingredients reach the market. Companies would need to notify FDA of their GRAS determinations and provide supporting documentation, though they could continue marketing without waiting for FDA approval.
United States Healthcare
AP
Arnold & Porter
Article
Autism Therapy Under The Microscope: Federal Guidance Signals Heightened Enforcement Focus On ABA Services
The Centers for Medicare & Medicaid Services has released a comprehensive 173-page toolkit addressing rising concerns in the autism therapy industry, where Medicaid spending has surged from $2 billion to $10.1 billion between 2021 and 2025. Federal audits have identified nearly $200 million in improper payments across multiple states, revealing systemic vulnerabilities in documentation, billing practices, and clinical oversight that are now driving unprecedented regulatory scrutiny and enforcement action.
United States Healthcare
BT
Barnes & Thornburg LLP
Article
CMS Enforcement Arsenal Expands To Share OIG’s Exclusion Authority
The Centers for Medicare & Medicaid Services has been granted unprecedented authority to exclude individuals and entities from federal healthcare programs, a power previously held exclusively by the HHS Office of Inspector General. This expansion raises critical questions about how the two agencies will coordinate exclusion decisions, particularly in False Claims Act settlements, and what criteria CMS will apply when wielding this significant enforcement tool. Healthcare providers and entities now face unce
United States Healthcare
SR
McDermott Will & Schulte
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Healthcare

Article
Autism Therapy Under The Microscope: Federal Guidance Signals Heightened Enforcement Focus On ABA Services
The Centers for Medicare & Medicaid Services has released a comprehensive 173-page toolkit addressing rising concerns in the autism therapy industry, where Medicaid spending has surged from $2 billion to $10.1 billion between 2021 and 2025. Federal audits have identified nearly $200 million in improper payments across multiple states, revealing systemic vulnerabilities in documentation, billing practices, and clinical oversight that are now driving unprecedented regulatory scrutiny and enforcement action.
United States Healthcare
BT
Barnes & Thornburg LLP
Article
Predictions Realized: Regulators And Enforcement Authorities Dial Up The Heat On Prediction Markets While Event Contracts Expand Into Clinical Trial Outcomes And FDA Approvals - What Companies Need To Know
Federal regulators are establishing frameworks for prediction markets while prosecutors pursue insider trading cases, creating new compliance challenges for companies. Life sciences firms face heightened risks as platforms launch event contracts tied to clinical trial outcomes and FDA approvals, potentially compromising data integrity and trial conduct.
United States Commercial
HL
Hogan Lovells Cadwalader
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Food and Drugs Law

Article
FDA’s Proposed GRAS Rule: Mandatory Notifications, Expanded Scope, And Open Questions
The FDA has proposed a rule that would fundamentally transform how food substances enter the U.S. market under the Generally Recognized as Safe (GRAS) framework, converting what has been a voluntary notification system into a mandatory disclosure requirement. Companies would be required to notify FDA of their GRAS conclusions before or shortly after introducing substances into interstate commerce, though the rule stops short of creating a premarket approval system. The proposal raises critical questions abo
United States Healthcare
KD
Kelley Drye & Warren LLP
Article
FDA Proposes Mandatory GRAS Notification Requirement
The U.S. Food and Drug Administration has proposed converting its voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory requirement, fundamentally reshaping how food ingredients reach the market. Companies would need to notify FDA of their GRAS determinations and provide supporting documentation, though they could continue marketing without waiting for FDA approval.
United States Healthcare
AP
Arnold & Porter
Article
Fresenius Kabi And Dr. Reddy’s Announce FDA Approval Of Rituximab Biosimilar
Fresenius Kabi and Dr. Reddy's Laboratories have received FDA approval for a rituximab biosimilar, marking another entry into the competitive market for alternatives to Genentech's RITUXAN. The approval, supported by comprehensive analytical, non-clinical, and clinical data, positions this biosimilar alongside three other FDA-approved rituximab alternatives already on the market.
Worldwide Healthcare
GP
Goodwin Procter LLP
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Life Sciences, Biotechnology & Nanotechnology

Article
Fresenius Kabi And Dr. Reddy’s Announce FDA Approval Of Rituximab Biosimilar
Fresenius Kabi and Dr. Reddy's Laboratories have received FDA approval for a rituximab biosimilar, marking another entry into the competitive market for alternatives to Genentech's RITUXAN. The approval, supported by comprehensive analytical, non-clinical, and clinical data, positions this biosimilar alongside three other FDA-approved rituximab alternatives already on the market.
Worldwide Healthcare
GP
Goodwin Procter LLP
Article
FDA Issues Its First Freeze-Dried Plasma License
The FDA has licensed EZPLAZ™ FDP, marking a significant milestone as the first freeze-dried plasma product approved in the United States. This innovative biologic offers unique storage advantages over conventional frozen plasma products, with potential applications in emergency, disaster, combat, and remote care settings. The product's room-temperature stability and rapid reconstitution capabilities address critical challenges in plasma availability when traditional products are not accessible.
United States Healthcare
GP
Goodwin Procter LLP
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