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June 24, 2020

External Resources and Information Related to Patients’ Experience

This webpage is intended to facilitate public discussion of patient-focused drug development and evaluation. This webpage provides links to certain publicly available external reports and resources […]
June 24, 2020

La FDA aconseja a los consumidores no usar productos para desinfectar manos que hayan sido fabricados por Eskbiochem

English version [junio 19, 2020] La FDA advierte a los consumidores no usar ningún desinfectante para manos fabricado por Eskbiochem SA de CV de México, debido a […]
June 24, 2020

Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment

Docket Number: FDA-2010-D-0589 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [updated: 6/24/2020] The purpose of this guidance is to assist sponsors and […]
June 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020

For Immediate Release: June 23, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
June 23, 2020

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials

For Immediate Release: June 23, 2020 The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence […]
June 23, 2020

Drug Trials Snapshots: UPLIZNA

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
June 23, 2020

Central Admixture Pharmacy Services, Inc. – 498479 – 06/17/2020

Delivery Method: Certified Email Product: Drugs Recipient: Recipient Name Thomas J. Wilverding Recipient Title President Central Admixture Pharmacy Services, Inc. 6580 Snowdrift RoadSuite 100Allentown, PA 18106-9331United […]
June 23, 2020

FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure […]
June 23, 2020

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment

Docket Number: FDA-2009-D-0136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [Updated: 6/24/2020] Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment This guidance does […]
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