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FDA Guidance on EpCAM-Positive Cell Reduction by Filters
The FDA has issued guidance concerning the reduction of EpCAM-positive cells by filters. This document provides information relevant to drug manufacturers and medical device makers.
FDA Medical Device User Fee Rates for FY 2024
The Food and Drug Administration (FDA) has posted the Medical Device User Fee rates for Fiscal Year 2024. This notice provides the updated fee schedule for medical device manufacturers.
FDA Economic Analysis of CDRH Submission Requirements
The FDA has published an economic analysis concerning the submission requirements for the Center for Devices and Radiological Health (CDRH). This analysis provides insights into the economic impact of these requirements on medical device manufacturers.
FDA PRIA Reference SBA Size Standards Update
The FDA has posted an update regarding the Presolicitation Information and Analysis (PRIA) Reference, specifically concerning Small Business Administration (SBA) size standards. This notice updates the reference document used by the agency for certain regulatory processes.
FDA PRIA Reference Data
The FDA has published reference data related to the Prescription Drug User Fee Act (PRIA) for May 2024. This notice includes national employment data relevant to PRIA submissions. It serves as an informational update for regulated entities.
FDA Document on Biochemical Changes in Red Blood Cells
The FDA has posted a document concerning biochemical changes in red blood cells. The document is available for review on Regs.gov, though specific details are restricted due to copyright.
CMS Medicare Data Application for Performance Measurement Comment Period
The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on its intention to collect information related to Medicare data applications for performance measurement. This notice is part of the Paperwork Reduction Act process, requiring a 60-day public comment period.
CMS Seeks Public Comment on Information Collection
The Centers for Medicare & Medicaid Services (CMS) is seeking public comment on its intention to collect information from the public under the Paperwork Reduction Act. The notice provides a 60-day comment period for interested parties to submit feedback on the proposed information collection.
CDC Draft IDLH Value Profile for Lewisite
The CDC has released a draft Immediately Dangerous to Life or Health (IDLH) value profile for Lewisite. This document is open for public comment and provides scientific information to inform occupational safety standards.
NIOSH Seeks Public Comment on Draft Lewisite IDLH Value Profile
The CDC's NIOSH is requesting public comment on a draft Immediately Dangerous to Life or Health (IDLH) Value Profile document for the chemical lewisite. The comment period closes on May 18, 2026.