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Guidance on Microbiological Quality in Non-Sterile Drugs

[ Price : $8.95]

FDA publishes a draft guidance on microbiological quality control of non-sterile drugs.

Tropical Disease Review Voucher Fee Rate

[ Price : $8.95]

Federal Register notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2022 $1...

Rare Pediatric Disease Priority Voucher Fee

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 202...

Fee Rate for Medical Countermeasure Voucher

[ Price : $8.95]

Federal Register notice: FDA sets the fee rate for using a material threat medical countermeasure priority review voucher for fisc...

Drug, Biologicals Benefit/Risk Assessment Guidance

[ Price : $8.95]

FDA publishes a guidance on benefit/risk assessment in NDAs and BLAs.

3 Ex-FDA Lawyers Join Sidley

[ Price : $8.95]

Sidley says three former FDA attorneys have joined its Global Healthcare and FDA practice.

Use Data-Driven Approach to Drug Analysis: Researchers

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University of Chicago researchers say FDA should use a more data-driven approach to postmarket drug surveillance to avoid falsely ...

FDA Clears NeuroSENSE Monitor

[ Price : $8.95]

FDA clears NeuroWave Systems NeuroSENSE bilateral brain monitor to assess the adequacy of anesthesia and sedation in clinical sett...

Radiation Exposure with Disinfectant Wand

[ Price : $8.95]

FDA issues a warning about the potential risk of injury associated with the use of Max-Lux Corp.s Safe-T-Lite UV Wand because use...

FDA OKs Mirums Livmarli for Rare Liver Disease

[ Price : $8.95]

FDA approves Mirums Livmarli to treat cholestatic pruritus in patients with Alagille syndrome age one and older.