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FDA Approves Jynneos Smallpox and Monkeypox Vaccine

[ Price : $8.95]

FDA approves Bavarian Nordics Jynneos smallpox and moneypox vaccine.

Draft Guide on Patient Input on Device Trials

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Federal Register notice: FDA makes available a draft guidance entitled Patient Engagement in the Design and Conduct of Medical Dev...

Guide on ALS Drug Development

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FDA issues a final guidance entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.

Medtronics New TAVR System Approved

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FDA approves Medtronics Evolut Pro+ Transcatheter Aortic Valve Replacement System.

Guide on Complex Innovative Clinical Trial Designs

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Federal Register notice: FDA makes available a draft guidance entitled Interacting with the FDA on Complex Innovative Clinical Tri...

Guide on Device Accreditation/Conformity Pilot

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Federal Register notice: FDA makes available a draft guide entitled The Accreditation Scheme for Conformity Assessment Pilot Progr...

Device Trials and Patient Engagement Guide

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FDA posts a draft guidance on patient engagement in medical device clinical trials.

Guide on Moving Animal Antimicrobials to Rx-only

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FDA posts a draft guidance for industry on recommendations for changing medically important animal antimicrobial drugs from over-t...

Bill Seeks to Make Pediatric Vouchers Permanent

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Bipartisan House members introduce the Creating Hope Reauthorization Act to make permanent a priority review voucher program for p...

CDRH Health of Women Program Strategic Plan

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CDRH seeks comments on a just-released Health of Women Program Strategic Plan that aims to explore the unique issues related to th...