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Full-Service Drug Development With The 505(B)(2) Process

A 505(b)(2) is a U.S. FDA new drug application (NDA) that contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This method gains approval for new or reformulated drugs in a fraction of the time and cost required by traditional paths.


In Europe, a similar regulatory approval route is the hybrid procedure based on Article 10 of Directive 2001/83/EC, which states:


Hybrid applications differ from generic applications in that the results of appropriate preclinical tests and clinical trials will be necessary in the following three circumstances:

  • Where the strict definition of a ‘generic medicinal product’ is not met;
  • Where the bioavailability studies cannot be used to demonstrate bioequivalence;
  • Where there are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference medicinal product.


This procedure covers equivalent development steps that would qualify for 505(b)(2) applications in the United States, such as changes in drug indications, pharmaceutical forms or route of administration. However, the hybrid procedure does encompass some situations that would be handled in the United States by an Abbreviated New Drug Application (ANDA) with a required clinical endpoint study. The EMEA hybrid scheme (Article 10b) also provides for fixed combinations of existing drugs.


Camargo can manage every facet of the plan throughout your development continuum, including feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission. From concept through commercialization, Camargo will be by your side every step of the way — you might even say we’ll be your best friend.


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