November 6, 2007
Camargo Pharmaceutical Services Announces Education Series on FDA 505(B)(2) Approval Route
Camargo Pharmaceutical Services, a leading provider of comprehensive drug development services, announced an education series on 505(b)(2) submission to the United States Food and Drug Administration (FDA). The senior management team at Camargo are industry experts in the development of strategic programs utilizing this approval route.
The 505(b)(2) approval pathway is typically used for drugs that were previously approved by the FDA and have been repositioned-- for example, either for a different indication or delivery mechanism. Knowledge of this process and its applicability to a specific compound can significantly streamline the development process. The education series appears as a part of a blog available via www.camargopharma.com; it will focus on answering such questions as:
Types of studies needed
Estimated study costs
Timelines from study initiation to FDA submission
Drug repositioning and the potential return on investment
"The term 'drug repositioning' has numerous connotations. The overwhelming response to our educational workshops and need for information expressed by our clients prompted me to present the material in an online, complimentary fashion. The blog allows for active conversation and information exchange," said Ken Phelps, president and CEO of Camargo.
"Historically, we've found that many people think the 505(b)(2) pathway is much like the 505(b)(1)--that is a costly mistake in terms of time and money in the drug development process. Our initial focus will be to provide the reader with information on why it is important to examine drugs from many points of view: scientific, medical, regulatory, financial and marketing," said Phelps. "Camargo is truly unique. Our company provides the drug development community with access to a cross-sectional team of experts to implement their program."
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services focuses on strategic drug development program design and implementation, from end-to-end or at any intermediate stage. The services include pre-clinical feasibility assessments, CMC and CMO services, clinical program development, pharmacokinetics, CRO services, Phase I through IV studies and clinical trials, to regulatory review and submission via eCTD of INDs, NDAs, ANDAs, and 505(b)(2)s. Tel: 888/451-5708 or [email protected]