Hamilton Medical recalls its Hamilton-C1, C2, C3, and T1 ventilators after receiving reports about software issues that may cause the devices to stop ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Extralabel Drug Use in Animals -- 21 CFR 530.
Federal Register notice: FDA seeks comments on an information collection extension entitled Dispute Resolution Procedures for Science-Based Decisions ...
FDA publishes a guidance to assist drug supply chain stakeholders to meet the requirements for enhanced drug distribution security at the package leve...
FDA issues two compliance guidances to implement a one-year stabilization period giving trading partners additional time to meet Drug Supply Chain Sec...
Five stakeholders respond to FDA docket questions about expanding home medical technology use.
FDA approves a five-year $50 million contract renewal with the University of Maryland Center of Excellence in Regulatory Science and Innovation.
FDA clears an Aion Biosystems 510 (k) for its iTempShield device and software system for continuous measurement of body temperature.
