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      Modular Learning: Operations

      • Home
      • Modular Learning
      • Operations
      Modular LearningOperations
      • Who is the Patient? 4

        • Section1.1
          Introduction
        • Section1.2
          Precision/Personalization, Segmentation, and Incidence/Prevalence
        • Section1.3
          Patient Journey
        • Section1.4
          Expansion/Secondary Indications
      • Standard of Care & Competition 4

        • Section2.1
          Introduction
        • Section2.2
          Unmet Need, Safety, Efficacy, Compliance, Costs
        • Section2.3
          Development Pipeline Analysis/Competitive Intelligence
        • Section2.4
          Competition in Therapeutics (5 forces)
      • Business Model 4

        • Section3.1
          Introduction
        • Section3.2
          Product, Platform or Service
        • Section3.3
          Mission, Vision, Strategy, Tactics, Operations
        • Section3.4
          Who is the Customer?
      • Regulatory 4

        • Section4.1
          Introduction
        • Section4.2
          FDA Introduction
        • Section4.3
          FDA Guidelines
        • Section4.4
          Selecting FDA Consultants
      • Exit/End Goal 4

        • Section5.1
          Introduction
        • Section5.2
          Trade Sales
        • Section5.3
          Sales
        • Section5.4
          Partnerships

        FDA Introduction

        Introduction

        The pharmaceutical industry is of great importance to the economy, providing both tax revenues and jobs. Hence it, and the regulation of it, has become a political topic as well. Despite the political vitriol you may hear in the popular press, the FDA is a non-partisan, progressive, highly sophisticated agency, filled with domain experts across the spectrum of therapeutics development, and well beyond. When they say “no”, they’re vilified, and when they say “yes”, the developer is the hero. It’s a demanding and difficult role, and you should expect exceptional expertise.

        What

        The FDA is tasked with protecting human health broadly; their therapeutics regulatory role is only a small part of their remit. Understanding the Agency’s 9 organizational structure is necessary to begin to engage with the experts within.

        When

        Planning for regulatory can begin as soon as the product is conceptualized. Actively developing regulatory strategy and documentation typically begins as preclinical Proof of Concept is achieved. FDA has a number of mechanisms for communication and feedback. Understanding when to and how to use them will save time, money and energy.

        Why

        Without regulatory approval, your therapy cannot touch a patient, nor be sold in the market.

        Learning Goals

        FDA’s role in therapeutics development, standard and special (breakthrough, fast track, priority review, and accelerated approval) pathways, and other useful regulatory resources.

         

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