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Biologics

FDA Approves Jynneos Smallpox and Monkeypox Vaccine

FDA approves Bavarian Nordics Jynneos smallpox and moneypox vaccine.

Federal Register

Draft Guide on Patient Input on Device Trials

Federal Register notice: FDA makes available a draft guidance entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Investi...

Human Drugs

Guide on ALS Drug Development

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

Medical Devices

Medtronics New TAVR System Approved

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

Human Drugs

Guide on Complex Innovative Clinical Trial Designs

Federal Register notice: FDA makes available a draft guidance entitled Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs...

Federal Register

Guide on Device Accreditation/Conformity Pilot

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

Medical Devices

Device Trials and Patient Engagement Guide

FDA posts a draft guidance on patient engagement in medical device clinical trials.

Animal Drugs

Guide on Moving Animal Antimicrobials to Rx-only

FDA posts a draft guidance for industry on recommendations for changing medically important animal antimicrobial drugs from over-the-counter to prescr...

Human Drugs

Bill Seeks to Make Pediatric Vouchers Permanent

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

Medical Devices

CDRH Health of Women Program Strategic Plan

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