DESI Drugs

Camargo Pharmaceutical Services’ customized approach to navigating the 505(b)(2) pathway presents the opportunity to secure approval for DESI (Drug Efficacy Study Implementation) drugs. DESI drugs on the market today have not been approved with a NDA under current FDA restrictions, due to the 1962 Kefauver-Harris Amendment to the 1938 FD&C Act requiring that drugs not only be proven safe, but also efficacious. By effectively utilizing the 505(b)(2) development process, many of these drugs qualify for 5 years of data exclusivity.

You need an expert on your side.

With our expertise in end-to-end drug development, Camargo will work with you to prepare a comprehensive plan for approval. This plan includes an assessment study and gap analysis for presentation and submission to the FDA for concurrence.

As part of an assessment study, our process begins with the review of the drug information as it exists in the public domain. The goal is to find data that can be used in lieu of sponsor studies. Camargo is able to develop and analyze what information is pivotal to pre-clinical (toxicology), safety and efficacy requirements in a NDA. In conjunction with known information on similar compounds, Camargo then can establish the gap (i.e., how many and what other studies are necessary, as well as projected costs and duration estimates).

Camargo compiles and presents this information for your pre-IND meeting with the FDA so you can be assured your clinical trial program is on target, using the minimum studies. With our expert staff by your side throughout each phase, you can rest assured that all trials will be designed with appropriate protocols and conducted to obtain the necessary data for FDA approval.