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FDA General

FDA Medical Product Programs Benefit in Budget Request

New budget document shows that FDAs medical product programs could benefit most from the Trump Administrations proposed 7% boost ($419 million) to the...

Federal Register

Info Collection on Device Symbols in Labeling

Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices: Use of Symbols in Labeling Glossary to Suppor...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/15/2019.

Federal Register

Clinical Trial Enrichment Strategies Guide

Federal Register notice: FDA makes available a final guidance entitled Enrichment Strategies for Clinical Trials to Support Demonstration of Effective...

Federal Register

Guide on Hematologic Disorders Drug Development

Federal Register notice: FDA makes available a final guidance entitled Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical De...

Federal Register

Draft Guide on Clinical Trial Sponsor Monitoring

Federal Register notice: FDA makes available a draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and A...

Federal Register

Guidance on Animal-sourced Materials in Devices

Federal Register notice: FDA makes available a final guidance on Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro...

FDA General

What Grounded Boeings and FDA Have in Common

FDA Webview editor Jim Dickinson sees a troubling parallel between the influence Boeing has had at FAA and the same post-Reagan influence that industr...

Medical Devices

Advisory Panel to Mull Device Metal Hypersensitivity

FDA plans an advisory committee meeting to discuss nitinol and other metals in device implants to understand the potential risk for certain patients t...

Medical Devices

FDA Finds Increased Mortality with Paclitaxel Devices

An updated FDA safety alert on paclitaxel-coated products says that a preliminary data review has identified a potentially concerning signal of increa...