FDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, subject to special controls to ensure safety and effectiveness.
The FDA issues a final 5-year debarment order against Andrew Jonathan Morgan, prohibiting him from importing or offering for import any drug into the United States based on a federal felony conviction related to drug importation.
USDA amends Title VI Civil Rights Act regulations to eliminate disparate-impact liability and align with Department of Justice standards under Executive Order 14281, reducing compliance costs for regulated entities.
FDA classifies ingestible gastrointestinal blood detection capsules as class II devices, establishing special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
Medicare's final rule strengthens oversight of accrediting organizations by addressing conflicts of interest, establishing consistent standards, and updating validation systems for deemed providers and suppliers across multiple care settings.
The EPA will transfer pesticide product data and claimed confidential business information to the Department of Justice and litigation parties under FIFRA and FFDCA disclosure rules.
FDA corrects withdrawal of approval for 11 abbreviated new drug applications; Masuu Global Solutions LLC's propranolol and lidocaine ANDAs remain approved as of March 23, 2026.
EPA releases draft risk evaluation of flame retardant TBBPA under TSCA and requests public comment on whether the chemical presents unreasonable health or environmental risks under current use conditions.
Proposed rule codifies Medicare Drug Price Negotiation Program under the Inflation Reduction Act of 2022 and establishes new policies for drug benefit programs and fixed combination drugs.
CMS is soliciting public comments on proposed information collection activities under the Paperwork Reduction Act; interested parties may submit feedback on burden estimates and collection methodology.
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