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April 18, 2023

Rezafungin Injection

Recognized Interpretive Criteria FDA identified interpretive criteria   Minimum Inhibitory Concentrations(mcg/mL)Broth Microdilutionat 24 Hours Disk Diffusion(zone diameters in mm)Disk Diffusion at 24 Hours Pathogen S I […]
April 18, 2023

Piperacillin Tazobactam – Injection products

Recognized Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales* ≤8/4 16/4 ≥32/4 ≥25 21-24 ≤20 Pseudomonas aeruginosa […]
April 18, 2023

Chemical Services Group, Inc./Royal Chemical Company – 648378 – 04/05/2023

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Matt Dailey Recipient Title CEO & President Chemical Services Group, Inc./Royal Chemical Company 8679 South Freeway […]
April 18, 2023

Zermat International S.A. de C.V. – 647232 – 04/06/2023

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Mr. Adelfo Enriquez Rios Recipient Title President and CEO Zermat International S.A. de C.V. Calle Lazaro Cardenas […]
April 18, 2023

ByPro Nutrition LLC – 646308 – 04/04/2023

Delivery Method: VIA UNITED PARCEL SERVICE Product: DrugsFood & Beverages Recipient: Recipient Name Dr. Robert L Bynum Recipient Title Owner ByPro Nutrition LLC 1906 Potomac Dr.Columbia, […]
April 18, 2023

Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy – 653740 – 03/31/2023

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Rob Kilgore Recipient Title CEO Belmar Pharma Solutions, Drug Depot, LLC., dba APS Pharmacy 12860 W. […]
April 18, 2023

Eco Lips, Inc. – 631629 – 09/20/2022

Delivery Method: UPS Product: Drugs Recipient: Recipient Name Glen A. Jasper Recipient Title President and Chief Sales Officer Eco Lips, Inc. 6000 Huntington Ct. NECedar Rapids, […]
April 17, 2023

FDA CDER and CBER & Duke-Margolis Center for Health Policy | Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development – 06/07/2023

On This Page Date: June 7 – 8, 2023 Day1: Wed, Jun 7 1:00 PM – 5:00 PM ET Day2: Thu, Jun 8 1:00 PM – […]
April 14, 2023

Drug Trial Snapshot: EMPAVELI

What are the possible side effects (results of trials used to assess safety)? The table below summarizes adverse reactions in the Trial APL2-302. Treatment-Emergent Adverse Events […]
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