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Graft-versus-Host Disease Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Graft-versus-Host Diseases: Developing Drugs, Biological Pr...

De Novo Device E-filing Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Electronic Submission Template for Medical Device De Novo R...

Guide on Device Antimicrobial Testing

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Antimicrobial Susceptibility Test (AST) System Devices Upd...

Guide on Drug Dose Banding

[ Price : $8.95]

FDA posts a final guidance entitled Human Prescription Drug and Biological Products Labeling for Dosing Based on Weight or Body S...

FDA Approves Biogens Actemra Biosimilar

[ Price : $8.95]

FDA approves a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody refer...

Generics Office Expands In-person Meetings

[ Price : $8.95]

CDERs Office of Generic Drugs Office (OGD) expands its post-pandemic return to in-person face-to-face meetings with industry.

Pilot Seeks to Advance Rare Disease Drugs

[ Price : $8.95]

FDA announces a new pilot program to further accelerate the development of novel drug and biological products for rare diseases. ...

AST Device Labeling Breakpoints Guidance

[ Price : $8.95]

FDA says it is implementing immediately a new guidance with information about updating susceptibility test interpretive criteria b...

De Novo e-Submission Template Guidance

[ Price : $8.95]

FDA publishes a draft guidance on the electronic submission format for de novo medical device requests.

Petition Seeks Warning on Fluoroquinolone Guides

[ Price : $8.95]

Three people petition FDA to add information from the fluoroquinolone Boxed Warning to the top of the drugs Medication Guide as a ...