May 26, 2023

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products

Submit Comments by 08/24/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
May 26, 2023

FDA updates on hand sanitizers consumers should not use

Yiwu Mango Cosmetics, Ltd.(China) Instant Hand Sanitizer (Alcohol 75%) 76824-001-0176824-001-0276824-001-0376824-001-0476824-001-0576824-001-0676824-001-0776824-001-0876824-001-0976824-001-1076824-001-1176824-001-1276824-001-13 Yiwu Mango Cosmetics, Ltd.(China) Product manufactured at a facility that did not respond to multiple FDA […]
May 26, 2023

CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products | COVID-19

To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, CDER is disclosing information from our scientific review […]
May 25, 2023

Guidance Recap Podcast | Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

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 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 […]
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