Regulatory Development Strategies

The optimal regulatory drug development and registration strategy outlines rapid drug development, timely FDA review and approval, and expeditious market launch. The strategy should also take into consideration mechanisms for protection from competition whether through patent protection or market exclusivity provisions. Developing a regulatory strategy requires a multifaceted analysis that integrates all aspects into a development plan and timeline. With the product's clinical attributes as the basis for consideration, the analysis should address potentially viable indications, unmet medical needs, regulatory "opportunities," analyses of competitors' registration strategies (including approved products and those in development), medical practice guidelines for disease treatments of national societies, FDA advisory committee meetings and transcripts, and strategies for market protection through patents and market exclusivity. Competitive consideration dictates the labels of related products be carefully read, with the intent of developing a regulatory strategy that will lead to a competitive edge in the label. Key differentiating features could be the product's dosing regimen, administration, special populations, and monitoring parameters. The regulatory strategy for a first product in a phar-macologic class will typically differ from the regulatory strategy for those products that follow in the same class.

In general, the more life-threatening or severely debilitating the illness where no adequate therapy exists, the shorter the drug development timeline and the lower the hurdle will be for FDA approval of the product. The registration strategy for the development of a "me-too" product must take into account the expectations of FDA set by the approval packages of other products in the same drug class and the intensely competitive environment. Successful integration of these areas benefits the patients because they have access to innovative therapies as quickly as possible. The sponsor benefits because it can begin to receive a return on its investment as soon as possible. Regardless of the strategy, in order for it to be successful in the end, the data must demonstrate that the benefits of the drug product outweigh the risks in the target patient population.

The FDA has developed regulations and performance targets that accomplish a variety of goals including faster FDA review and approval timelines, incentives to innovators to study drugs in patients with rare diseases, mechanisms for taking appropriate prescription products to over-the-counter status, and pediatric indications for existing and new products (Fig. 7.12). This section specifically addresses some of these regulatory opportunities.

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