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HOW TO ENSURE A SUCCESSFUL FDA MEETING

June 13, 2019
USA (United States of America)
When developing a drug, biologic or combination product for approval, early and successful interactions with the US Food and Drug Administration (FDA) can reduce both costs and time to approval. Developing a strong relationship with the product’s review division is crucial in ensuring that the agency is knowledgeable about the product and supports the development. Formal meetings with the FDA will strengthen this relationship and allow them to provide input on product and program development plans. In this webinar, John Balser, Barbara Balser and Mara Holinger will discuss methods for ensuring a successful FDA meeting and developing a collaborative relationship. They will touch on why it is important to ask the right questions and provide the appropriate background information for the most successful outcomes. The speakers will share their tips and tricks based on years of experience and positive outcomes from FDA meetings.