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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!