FDA Center for Drug Evaluation and Research - What's New 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop - 04/16/2024
PQRI/EUFEPS Global Bioequivalence Harmonisation Initiative (GBHI): 6th International Workshop (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Quality, Current Good Manufacturing Practice Inspections and Compliance
Hospitals, health systems and patients rely on FDA to ensure the medications that are available are safe, effective and of high quality. For application products, typically prescription drugs, FDA ’s approval process is the first step. FDA’s drug application approval includes assessing the manufactur (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Announces New Quality Oversight Webpage
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease
The FDA approved the first medication for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring, to be used along with diet and exercise. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Trials Snapshots: COLUMVI
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Q & A with FDA Podcast
“Q&A with FDA ” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 14, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Govvi WOW! contains hidden ingredients
The Food and Drug Administration is advising consumers not to purchase or use Govvi WOW!, a product promoted and sold for weight loss on various websites, including www.ebay.com and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Drug Development for the Treatment of Congenital Cytomegalovirus Infection and Neonatal Enterovirus Infection - 05/07/2024
The Food and Drug Administration is holding a public, two-day workshop entitled Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 13, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution
Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulate (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
FDA Roundup: March 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Computational Simulations Shed Light on Factors Affecting Nasal Spray Distribution
In this series of simulations, researchers in CDER and external collaborators studied how different factors may affect corticosteroid nasal deposition (where the drug particles land in the nose) and, relatedly, nasal distribution (where the drug particles ultimately ‘reside’). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Laboratory Study Shows Oral Antacid Drug Performs Differently When Mixed with Various Food Vehicles
“Sprinkling” a drug into food vehicles can be an alternative for these patients. Sprinkle formulations are drug-containing pellets or granules that can be mixed with soft foods or drinks before administration. Sprinkling can improve patient compliance. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
Frailty measures that use patient self-reports called “patient-reported outcomes” (PROs) can provide scientific information on a patient’s experience coming directly from patients. PROs can offer valuable information about a patient’s own health, quality of life, and functional capabilities, (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints
FDA Research Focused on Direct-to-Consumer Television Advertising (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
