Introduction and Overview Lilliam Rosario, Ph.D. Director, Office - PowerPoint PPT Presentation

Introduction and Overview Lilliam Rosario, Ph.D. Director, Office of Computational Science 2019 PhUSE CSS

Disclaimer Statement Disclaimer The views and opinions presented here represent those of the speakers and should not be considered to represent advice or guidance on behalf of the U.S. Food and Drug Administration. 2

Topics 2019 PhUSE CSS IND Mission Application Food and Drug Administration New Drug Phases of Application Clinical (NDA) Testing The The Review Review Process Timeline 3

Mission The mission of the FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective CDER is the largest of the FDA's six centers. It has responsibility for both prescription and non-prescription or over-the-counter (OTC) drugs. 4

IND Application Sponsors-companies, research institutions, and other organizations take responsibility for developing a drug. They must show the FDA results of preclinical testing in laboratory animals and what they propose to do for human testing. FDA decides whether it is reasonably safe for the company to move forward with testing the drug in humans. Clinical Trials - Drug studies in humans can begin only after an IND is reviewed by the FDA. 6

Phases of Clinical Testing Phase 1 studies determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. Emphasis is on safety. Phase 2 studies aim to obtain preliminary data on whether the drug works in people who have a certain disease or condition. The emphasis is on effectiveness. Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. 8

New Drug Application What does an NDA include? What is an NDA? • All animal and human data The formal step a drug • Analyses of the data sponsor takes to ask that • Information about how the drug behaves in the body the FDA consider • How the drug is manufactured approving a new drug for marketing in the United States 60 The FDA can refuse to file an Days application that is incomplete For the FDA to decide whether to file, so the NDA can be reviewed CDER expects to review and act on at least 90% of NDAs for standard drugs no later than 10 months after they are received. For priority drugs the review goal is six months. 10

The Review Process The official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency's decision. Once a new drug application is filed, an FDA review team evaluates whether the studies the sponsor submitted show that drug is safe and effective for its preferred use. The review team analyzes study results and looks for possible issues with the application. Reviewers determine whether they agree with the sponsor's results and conclusions, or whether they need any additional information to make a decision. Each reviewer prepares a written evaluation containing conclusions and recommendations about the application. These evaluations are then considered by team leaders, division directors, and office directors, depending on the type of application. Sometimes the FDA calls on advisory committees, who provide FDA with independent opinions and recommendations. 12

The Review Timeline 14

Meet the Team Chemist Clinical Nonclinical Clinical Statistician Reviewer Reviewer Pharmacologist 16

Introduction and Overview Lilliam Rosario, Ph.D. Director, Office - PowerPoint PPT Presentation

Introduction and Overview Lilliam Rosario, Ph.D. Director, Office of Computational Science 2019 PhUSE CSS Disclaimer Statement Disclaimer The views and opinions presented here represent those of the speakers and should not be considered to

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Introduction and Overview Lilliam Rosario, Ph.D. Director, Office - PowerPoint PPT Presentation

Introduction and Overview Lilliam Rosario, Ph.D. Director, Office of Computational Science 2019 PhUSE CSS Disclaimer Statement Disclaimer The views and opinions presented here represent those of the speakers and should not be considered to

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