Reference #: FEI 3006441852 Product: Drugs Recipient: Recipient Name Nathan Trembath Recipient Title General Manager Abraxis Bioscience LLC 620 N 51 St. Ave.Phoenix, AZ 85043United States […]

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Giovanni Caforio Recipient Title Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave.Phoenix, […]

[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development […]

On This Page Date: April 25, 2024 Time: 9:00 AM – 1:00 PM ET Location Zoom About This Event: This virtual workshop will be hosted by […]

eCTD Technical Conformance Guide Documentation and Resources 1.8 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 11/04/2022     eCTD Backbone […]

For Immediate Release: March 22, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Antimicrobial Regulatory Science Research Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]

Recognized Interpretive Criteria FDA Identified Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S SDDa I R S SDDa I R Enterobacteralesb ≤8/4 – […]

FDA has completed their review of the rationale document titled, “Piperacillin-Tazobactam Breakpoints for Pseudomonas aeruginosa” (MR15, January 2024), submitted by the Clinical and Laboratory Standards Institute […]