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.
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.
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.
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.
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.
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.
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.
Western Mixers Produce & Nuts recalls 9 oz. First Street brand Dark Chocolate Raisins due to undeclared peanuts posing serious risk to allergic consumers.
FDA draft guidance clarifies Forms FDA 3542a and 3542 submission requirements to assist industry applicants in preparing regulatory filings.
FDA amends regulations to direct the public to its website for organizational and contact information while revoking outdated regulations related to agency structure and contacts.
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