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.
AndersonBrecon, Inc. DBA PCI Pharma Services has applied for DEA registration as an importer of controlled substances; details on specific drug classes are available in supplementary information.
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.
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.
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.
DOJ's Office of Justice Programs seeks OMB approval for a new information collection on T visa certification letter requests; public comments accepted through the Federal Register notice period.
Western Mixers Produce & Nuts recalls 9 oz. First Street brand Dark Chocolate Raisins due to undeclared peanuts posing serious risk to allergic consumers.
Cerilliant Corporation seeks DEA registration as an importer of controlled substances; refer to supplementary information for specific drug classes.
Veranova, L.P. has applied for DEA registration as a bulk manufacturer of controlled substances; supplementary drug information is available in regulatory notices.
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