Product/Service

DESI (Drug Efficacy Study Implementation) Drugs Approval

Source: Camargo Pharmaceutical Services
Camargo will work with you to prepare a comprehensive plan to secure approval for DESI (Drug Efficacy Study Implementation) 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. The FDA's DESI program was enacted to evaluate the efficacy of all drug products approved and marketed on safety grounds alone between 1938 and 1962. Although these DESI-approved drugs may continue to be marketed until the administrative proceedings evaluating their effectiveness have concluded, continued marketing is permitted only if a new drug application (NDA) is approved for such drugs.

Currently, the FDA is pursuing an Unapproved Drugs Initiative against as many as 3,000 drugs still on the market without approval. For many of these drugs still in limbo, a direct path to an NDA and possible marketing exclusivity may be obtainable.

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.