JD Supra11h
Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in ...
Supreme Court Backs FDA Rejections of Flavored Vape Products
"[W]e conclude that the FDA’s denial orders were sufficiently consistent with its predecisional guidance and thus did not run afoul of the change-in-position doctrine," Justice Samuel Alito Jr. wrote ...
SCOTUSblog1d
Court tosses out lower-court ruling against FDA in flavored vape dispute
The Supreme Court on Wednesday largely upheld the Food and Drug Administration’s denials of two companies’ applications to sell flavored liquids for use in e-cigarettes. In a unanimous ruling, the ...
GovInfoSecurity8d
Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
U.S. News & World Report13d
FDA Unveils Transparency Tool for Easy Check of Contaminant Levels in Foods
One of the FDA's roles is to set tolerances, action levels, and guidance levels for contaminants in food to protect ...
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
The new entry to FDA’s database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods—Understanding and use of product bioburden data. Three of AAMI’s most notable ...
Fierce Pharma1d
Cellares' cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s ...
The Lancet3d
Sexual health and reproductive toxicity from cancer therapies
Communication between health-care professionals and individuals with cancer regarding the effects of treatment on sexual ...