United States: Food and Drugs Law

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Article
APHIS Requests Comment On Petition To Deregulate Insect-Resistant Soybean Developed Using Genetic Engineering
The USDA's Animal and Plant Health Inspection Service has received a petition from Pioneer Hi-Bred International seeking nonregulated status for a genetically engineered soybean variety designed to resist certain lepidopteran pests. APHIS has prepared a draft plant pest risk assessment concluding the modified soybean is unlikely to pose increased plant pest risk compared to conventional varieties, with public comments due by October 19, 2026.
United States Environment
BC
Bergeson & Campbell
Article
FDA Approves Ultragenyx’s GENGLYCOS™ Gene Therapy For GSDIa
The FDA has granted accelerated approval to Ultragenyx Pharmaceutical's GENGLYCOS gene therapy for treating glycogen storage disease type Ia in patients eight years and older. This marks the first FDA-approved treatment for this rare genetic disorder that prevents the liver from properly releasing glucose, requiring patients to maintain frequent raw cornstarch intake and strict dietary monitoring.
United States Healthcare
GP
Goodwin Procter LLP
Article
FDA Releases New Guidance Documents On When To Submit An ANDA Or 505(b)(2) Application And On Therapeutic Equivalence Evaluations
FDA has issued two new guidance documents clarifying the abbreviated drug approval pathways. The first revision provides sponsors with greater clarity on when to submit an ANDA versus a 505(b)(2) application, addressing procedural gaps and duplicate drug scenarios. The second final guidance offers deeper insight into how the agency assigns therapeutic equivalence ratings, including the process for securing an A-rating for 505(b)(2) products.
United States Healthcare
HL
Hogan Lovells Cadwalader
Article
Is The Global Shift To The Right Threatening International Cannabis Reforms?
International cannabis markets face critical political shifts as Brazil, France, and Germany approach elections that could reshape their medical marijuana programs. With right-wing governments already rolling back reforms in Colombia and threatening changes across Europe and Latin America, the durability of cannabis legalization now depends heavily on who controls government power.
Worldwide Government
HS
Harris Sliwoski
Article
EPA Announces Receipt Of Applications And Seeks Public Comment For New Pesticide Active Ingredients
The U.S. Environmental Protection Agency has announced receipt of applications to register three new active ingredients not currently included in any registered pesticide products, including a rare antimicrobial pesticide chemistry. The agency is opening a 30-day public comment period ending September 21, 2026, for stakeholders to provide input on these applications before EPA makes registration decisions under the Federal Insecticide, Fungicide, and Rodenticide Act.
United States Environment
BC
Bergeson & Campbell
Article
Biocon Launches Aflibercept Biosimilar In The United States
Biocon Limited has commercially launched YESAFILI (aflibercept-jbvf), a biosimilar to Regeneron's EYLEA, in the United States following settlement agreements that lifted previous injunction barriers. This marks the second aflibercept biosimilar available in the U.S. market, entering a competitive landscape where patent litigation continues to shape biosimilar entry strategies. The launch follows a complex legal journey involving multiple jurisdictions and settlement negotiations that ultimately permitted ea
Worldwide Healthcare
GP
Goodwin Procter LLP
Article
New York Department Of Environmental Conservation Virtual Stakeholder Meeting On August 27, 2026
The New York State Department of Environmental Conservation is preparing comprehensive revisions to its pesticide regulations and seeking stakeholder input on implementation of the Birds and Bees Protection Act, which will restrict neonicotinoid pesticides and treated seeds. A virtual meeting scheduled for August 2026 will cover certification requirements, commercial permits, pesticide use restrictions, and the critical agricultural waiver process for treated seeds before the 2029 effective date.
United States Environment
BC
Bergeson & Campbell
Article
Hikma v. Amarin: Supreme Court Examines Induced Infringement In The Context Of Generic Drug Labeling
Last month, the Supreme Court of the United States heard oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a landmark pharmaceutical patent dispute concerning whether a generic drug manufacturer may face liability for induced patent infringement after marketing a “skinny-label” generic that omits patented uses from its FDA-approved labeling.
United States IP
RP
Reavis Page Jump LLP
Article
Psychedelic Therapeutics Take Center Stage: FDA Announces Public Hearing And Finalizes Clinical Guidance
The FDA has announced a September 2026 public hearing to gather stakeholder feedback on the therapeutic use of psychedelic drugs in supervised settings, marking a significant federal policy shift following the Trump administration's Executive Order directing agencies to accelerate psychedelic drug research and approval. This development, coupled with newly released FDA guidance on clinical investigations, signals an evolving regulatory landscape that extends beyond traditional drug approval pathways into cl
United States Healthcare
FH
Foley Hoag LLP
Article
HHS-OIG Issues Favorable Opinion On Food-as-Medicine Program Offered By Federally Qualified Health Center
The U.S. Department of Health and Human Services Office of Inspector General issued a favorable advisory opinion on a federally qualified health center's food-as-medicine program that provides free produce to financially needy patients with chronic conditions. Despite finding no applicable safe harbor protections under federal anti-kickback laws, HHS-OIG declined to impose sanctions due to the program's robust safeguards and narrowly tailored design.
United States Healthcare
BT
Barnes & Thornburg LLP
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