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.C3TI Knowledge Repository
Centralized knowledge repository for clinical trial innovation (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
C3TI Demonstration Program Proposal Submission
Submitting content and format of the C3TI Demonstration Program Proposal (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
About CDER Center for Clinical Trial Innovation (C3TI)
C3TI brings together collective expertise and activities to foster integration and coordination across the different ongoing projects and initiatives within CDER around clinical trial innovation, and to maximize their collective impact on drug development productivity and clinical trial subject. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
C3TI Demonstration Program
Provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Frequently Asked Questions about CDER Center for Clinical Trial Innovation (C3TI)
The CDER Center for Clinical Trial Innovation's mission is to enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Bayesian Supplemental Analysis (BSA) Demonstration Project
C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Selective Safety Data Collection (SSDC) Demonstration Project
Offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection of certain types of data for drugs or biologics with a well-characterized safety profile. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
Streamlined Trials Embedded in clinical Practice (STEP) Demonstration Project
C3TI aims to promote the adoption of pragmatic design in clinical trials and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 15, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news
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
