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FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors - 10/16/2023
This workshop is intended for parties interested in continued advocacy for alternatives to traditional dose finding for oncologic drugs. The primary audience includes, clinical pharmacologists, pharmacometricians, pharmacologists/toxicologists, clinicians/healthcare providers, statisticians, patients, and patient advocates. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: April 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 - April 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 12, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Trials Snapshots: SKYCLARYS
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children
Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Psychoactive Drugs in Infants and Children--Clinical Evaluation
Clinical/Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry
Clinical Antimicrobial (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 11, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2015
Novel drugs (2015): A report on the more innovative products approved by FDA. These products often help advance clinical care to another level. Each year, FDA approves hundreds of new medications, most of which are variations of previously existing products, such as important new dosage forms of alr (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2016
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2017
When it comes to innovation in the development of new drugs and therapeutic biological products, FDA ’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2018
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA ’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2019
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA ’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2020
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2022
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news