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Download your FREE Whitepaper on 505(b)(2) NDA Applications!
505(b)(2) NDA Applications: Navigating the regulatory pathway and the importance of strategic partnering
A large number of prescription and over-the-counter drugs are marketed in the US without FDA review and approval because they pre-date current drug regulations. The FDA has started to crack down on these drugs, requesting that manufacturers complete the updated drug approval process. The path to submit a New Drug Approval (NDA) is complicated and tricky, but with clear planning and strategic partnering, there are several approaches to obtaining the necessary agency review and approval.
This whitepaper will:
Explain the pros and cons of the different types of NDAs
Outline the pathway for the 505(b)(2) NDA submission
Explain how strategic partnering will lessen the burden of getting FDA approval
Download the whitepaper now to learn more about 505(b)(2) applications!
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