FDA withdraws approval of SpecGx LLC's abbreviated new drug application for Methylphenidate Hydrochloride Extended-Release tablets in 27mg, 36mg, and 54mg strengths per the applicant's request.
FDA requests OMB clearance for information collection activities related to Current Good Manufacturing Practice regulations for Type A medicated articles and medicated feeds under the Paperwork Reduction Act of 1995.
FDA submission to OMB for Paperwork Reduction Act review of information collection requirements for dietary supplement manufacturing, packaging, labeling, and holding operations.
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.
DT MedTech's Hintermann Series Talar Implant recall affects 67 units of left ankle replacement devices with incorrect right-device labeling distributed nationwide across California, Arkansas, Arizona, Idaho and internationally to Peru and South Kore…
Medartis AG recalls 13 units of APTUS 5.0 cannulated compression screws (REF A-8216.50/1) nationwide due to off-center cannulation that may cause temporary health problems during bone fixation procedures.
Inter-Med LLC issues Class II recall of Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit (catalog 504600-28) due to 500 units nationwide containing incorrect Ferric Sulfate package insert with dangerous ingestion instructions.
Abbott Medical Merlin Patient Care System software Class II recall affects 11,182 pacemaker programmers nationwide due to potential communication failure during capture threshold testing.
Tell Bizmoon what your business does and we'll cut the Federal Register down to what actually matters.
Every rule is broken into specific to-dos with calendar dates.
We tell you which parts of your business each rule actually touches.
After healthcare come the capital-heavy sectors: trade, transportation, energy, and finance. If you operate in one of them, the volume of change is relentless.
No legal jargon. Read the impact in two sentences.
Email + dashboard pings the moment something changes.
