Food and Drug Administration's issuance of a document providing guidance on the Dear Health Care Provider letters format for the improvement of its important safety information communication.doi:10.1007/s40278-014-8602-0Fairbrother GDonauer S
New FDA Draft Guidance Impacts Seafood Importers and Processors Feb 15, 2024 On February 9, 2024, FDA issued “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE...
These risks result from interactions among the user, the use environment, and the device, and can greatly affect user and patient safety. This article mainly introduces the FDA's Guidance document 'Design Considerations for Devices Intended for Home Use'. This guidance provides recommendations for ...
Serological test developers may pursue an EUA by submitting information about their test, including their validation data, to the FDA for review.Tests that are issued an EUAare listed on the FDA’s EUA web page. FDA Actions To help ensure that health care providers have access to accurate tes...
This alert summarizes FDA's response as of March 23, to COVID-19, with an emphasis on the information the regulated industry needs to know as well as how you might be able to help. In particular, this alert discusses: Recent guidance from the federal government...
regulatory meetings and pathway and alignment with FDA guidance; future development of epetraborole for other forms of NTM; development of AN2-502998 for Chagas disease; development of epetraborole for melioidosis; development of compounds for infectious diseases and oncology targets; glo...
During aTAVR procedure, the surgeon inserts a pencil-thin tube called a sheath into a femoral artery in the leg. Through that sheath, the surgeon uses image guidance to send a balloon catheter through the artery to the aortic valve. The balloon is inflated to open the damaged heart valve ...
Calibration is important because it helps ensure accurate measurements, and accurate measurements are foundational to the quality, safety and innovation of most products and services we use and rely on every day. Few people realize the critical role and importance of calibration in their daily lives...
including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the FDA and is intended t...
The Company's technology in coal exploitation and production safety has secured a leading position in the global market, and that of clean coal-fired power generation and heavy-loaded railway transportation has secured a leading position in the domestic market. During the reporting period, the ...