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 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 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.

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 Radiology Devices Classification Regulatory Analysis

The FDA has published a regulatory analysis concerning the classification of radiology devices. This notice provides an overview of the agency's approach to classifying these medical devices, offering clarity to manufacturers and stakeholders.

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 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 Guidance on Physicochemical Characterization of Topical Drug Products

The FDA has issued final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). This guidance, which finalizes a draft from October 2022, provides recommendations to support bioequivalence demonstrations for generic topical products.

Vermont AG Charges Resident with Human Trafficking and Assault

The Vermont Attorney General's Office announced the arraignment of Richard Memoli, 69, on multiple felony and misdemeanor charges including human trafficking, sexual assault, and drug possession. The investigation was conducted by the Vergennes Police Department, and Mr. Memoli was ordered held without bail.

Former Nursing Assistant Charged with Stealing $9,000 from Elderly Resident

The Michigan Attorney General's office announced charges against Terrance Brown Jr., a former nursing assistant, for allegedly stealing nearly $9,000 from an elderly nursing home resident. Brown faces multiple felony charges related to larceny and financial transaction device fraud.