FD&C Act Section 505 - New Drug Approval

What it says

Section 505 establishes the requirement that a new drug cannot be introduced into interstate commerce without an approved application, defining the New Drug Application pathway under 505(b)(1) for full applications, 505(b)(2) for applications relying in part on existing safety and efficacy data, and 505(j) for generic drug applications relying on demonstrated bioequivalence to a reference product.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The specific approval pathway, 505(b)(1), 505(b)(2) or 505(j), determines what data package is required and what regulatory exclusivity and patent considerations apply, making pathway selection a foundational strategic decision early in development.
• A 505(b)(2) application allows reliance on FDA's prior findings of safety and efficacy for a previously approved product, combined with new data, offering a potentially faster pathway for products with some but not complete overlap with existing approved products.
• Manufacturing facility information and cGMP compliance status are integral components of any Section 505 application, connecting this foundational approval framework directly to the specific manufacturing requirements covered throughout the rest of Part 211.

What FDA inspectors look for

• This is a foundational statutory approval framework rather than a specific manufacturing practice - its practical connection to inspection is that facility and process information submitted as part of a Section 505 application must match what is actually implemented at the manufacturing site.
• Whether manufacturing changes implemented after approval were properly assessed against the specific commitments made in the original approved application.

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