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.
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.
Center for Scientific Review will hold closed meetings to review research grant applications and provide advice on scientific matters to the National Institutes of Health.
Center for Scientific Review amended notice of meeting for the National Institutes of Health scientific review group; meeting details and date available in Federal Register notice.
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 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.
Center for Scientific Review will hold closed meetings to review grant applications and personnel matters; specific dates and locations available upon request to the designated agency contact.
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.
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.
The National Cancer Institute offers licensing of the A1847 human ovarian carcinoma cell line, a BRCA1-deficient model for researchers studying cell cycle regulation, tumor suppression, and DNA damage repair drugs.
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