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505(b)(2)?
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IATI-BioMed Israel

June 10-12, 2013

Tel Aviv, Israel

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Why (505)(b)(2) is a Whole Different Animal
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Full-Service Drug Development With The 505(B)(2) Process

Camargo provides you with global, end-to-end drug development capabilities specializing in the 505(b)(2) pathway. A 505(b)(2) is a new drug application (NDA) that contains full safety and effectiveness reports, but allows at least some of the information required for U.S. FDA approval to come from studies not conducted by or for the applicant. This method helps companies gain approval for new or reformulated drugs in a fraction of the time and cost required by traditional paths. 

 

For companies in China looking to attain drug approval in the United States, the 505(b)(2) pathway presents several advantages to get products to market faster:
 

  • Gain regulatory/NDA approval more efficiently by utilizing existing foreign clinical data.
  • Certain botanical and nutraceutical drugs may be good candidates to elevate to an NDA. These complex drugs can often be developed through the 505(b)(2) pathway.
  • 505(b)(2) alleviates some of the competitive pressure in a rapidly growing market by offering an alternative for generics companies and those developing biobetters.

 

Camargo has the go-to experts to execute a spectrum of small and large molecular development programs with pharmaceutical and biotech teams working to gain drug approval in the United States.

 

Click here to learn more about our comprehensive service offerings.

 

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