Cincinnati, United States:
Pharmaceutical Services has successfully completed five Food and Drug
Administration (FDA) pre-IND meetings for 505(b)(2) products in the
month of June, including successful meetings with two of India’s
top 10 largest pharmaceutical companies.
In all meetings, the FDA concurred with Camargo’s recommended strategy,
giving clients a clear drug development pathway with costs and timing.
Camargo’s in-house pre-clinical, clinical and regulatory experts
leveraged hard-to-find public data and developed innovative study
designs to meet the FDA’s exacting standards, while minimizing client
A 505(b)(2) is a new drug application that contains full safety and
effectiveness reports, but allows at least some of the pivotal
information required for approval to come from studies not conducted by
or for the applicant.
Camargo, an end-to-end drug development service provider specializing in
process, provides expertise to companies in 26 countries in North
America, Europe, India and China with the opportunity to gain U.S.
approval for new or reformulated drugs in a fraction of the time and
cost required by traditional paths.
According to Ken
Phelps, Camargo president and CEO, “With numerous blockbuster drugs
coming off patent and the impending generic cliff, faster and cheaper
development can relieve the pressure of a congested generics
In 2006, approximately 20 percent of new drugs were approved through the
505(b)(2) process. Today, the percentage of new, small-molecule drugs
approved through this process exceeds 80 percent.
Typically, a new drug application approved under the FDA standard
505(b)(1) regulatory path takes as long as 15 years and a nine-figure
investment to work its way through the system.
Drugs approved under 505(b)(2) rely in part on data from existing drugs;
therefore, the drugs can be developed and achieve FDA approval in as
little as 30 months with only a fraction of the number of required
trials and at a much lower cost.
About Camargo Pharmaceutical Services
Pharmaceutical Services is an end-to-end drug development service
provider specializing in the 505(b)(2) approval pathway. Camargo works
with companies to develop comprehensive programs, managing every facet
of the plan from formulating and testing the drug product, to conducting
pre-clinical and clinical studies and FDA application submissions.
Connect with Camargo on LinkedIn,
the President’s blog
or visit www.camargopharma.com
for more information.
For Camargo Pharmaceutical Services
Kelly Sladek, 308-237-5567