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May 25, 2023

Sulbactam and Durlobactam Injection

  Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Acinetobacter-baumannii calcoaceticus complex ≤ 4/4 8/4 ≥ 16/4 ≥ 17 […]
May 25, 2023

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

For Immediate Release: May 25, 2023 Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral […]
May 25, 2023

From Our Perspective

FDA actions to continue to ensure the safety of the nation’s drug supply By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research One […]
May 25, 2023

CDER Conversations

CDER Conversation: The Evolving Role of Decentralized Clinical Trials and Digital Health Technologies Decentralized clinical trials and digital health technologies are gaining momentum in medical research, […]
May 24, 2023

Study Data Technical Conformance Guide – Technical Specifications Document

Docket Number: FDA-2014-D-0092 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking […]
May 24, 2023

Guidance Recap Podcast | Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Thank you for joining us for another episode of the Guidance Recap Podcast. My name is Kylie Haskins, and I am today’s host. In this episode, […]
May 24, 2023

Guidance Snapshot Pilot

Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance […]
May 24, 2023

Golean Detox US – 573404 – 04/29/2019

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Anh Thu Nguyen Recipient Title Owner Golean Detox US 4832 Central AveCharlotte, NC 28205-5844United States Issuing Office: […]
May 24, 2023

Azmedicinalshop.com – 111111 – 03/27/2019

Product: Drugs Recipient: Azmedicinalshop.com United States Issuing Office: United States TO:        Az Medicinal Shop FROM:        The United States Food and Drug Administration RE:        Notice of Unlawful […]
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