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Office of Translational Sciences Annual Report

[ Price : $8.95]

The CDER Office of Translational Sciences 2023 annual report lists achievements in seven program areas.

Mass Spectrometry Guide for Animal Drugs

[ Price : $8.95]

FDA posts a final guidance entitled Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.

Bill to Ban Tianeptine as a Supplement

[ Price : $8.95]

Sens. Durbin and Blumenthal introduce legislation to authorize FDA to ban the marketing of tianeptine, currently being sold as a d...

Thoratec Recalls HeartMate 3 and LVAS Implant Kit

[ Price : $8.95]

Abbotts Thoratec unit recalls its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak.

Apple Watch Qualified for AFib Trial Monitoring

[ Price : $8.95]

CDRH qualifies the Apple Watchs Atrial Fibrillation History Feature as a medical device development tool for use as a biomarker te...

Info Collection on New Animal Drug Regs

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Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational U...

Praise, Suggestions for Informed Consent Guide

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Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed c...

Decentralized Trials Time Has Come: Marks

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CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical tria...

NCPA Statement to FDA Compounding Session

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The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual dru...

FDA Recognizes Blood Labeling Standard

[ Price : $8.95]

FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling...