505(b)(2): Is it for you?

 

 

 

Overview

A 505(b)(2) is a new drug application which 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 drugs in a fraction of the time and cost required by traditional paths.

 

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The 505(b)(2) process

Today, 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from an existing or approved drug. Ideal candidates include:

 

  • New indications
  • Changes in dosage form, strength, formulation, dosing regimen or route of administration
  • New combination products
  • New active ingredients
  • Pro-drug of an existing drug

 

 

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505(b)(1) vs. 505(b)(2)

We can certainly assist with a complete, full 505(b)(1) application, but we are the industry leader in guiding sponsors through the 505(b)(2) process. Although there can be confusion on which process may be the best fit for a drug program, we will help you evaluate and discuss the ideal options for safety, speed and efficiency. The 505(b)(1) process is what the industry is familiar with; it is executed for new drugs like those discovered by big pharma versus the 505(b)(2) process, which takes an existing drug and makes small modifications, often significantly advancing the medication for the patients’ benefit.

 

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Is 505(b)(2) for you?

Camargo’s expertise in drug approval and thorough understanding of the FDA and its evolving standards will put your product on the fast-track to market. Specializing in the 505(b)(2) pathway globally, our team executes a spectrum of small and large molecule development programs. We provide expert advice grounded in years of industry and regulatory experience to take you from discovery to post-approval marketing, with a full range of services for pharmaceutical and biotech development teams.

 

Camargo can help you reach cost-effective solutions, increase speed-to-market time and aid you in maintaining regulatory compliance. We partner with you to develop a comprehensive program while executing every facet of the plan, from formulation and testing the drug product, to conducting clinical studies and preparing FDA submissions. Camargo is by your side through each step — you couldn’t ask for a better companion.

 

Click here to download Camargo’s white paper Understanding the 505(b)(2) Approval Pathway