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# New CDER Biologics Compliance Program Explained
- URL: https://www.fdaweb.com/new-cder-biologics-compliance-program-explained/
- Published: 2026-05-07T12:00:00.000Z
- Updated: 2026-09-14T13:38:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161107

The 4/14 CDER Compliance Program 7346.832M, “Prelicense and Preapproval Inspections of CDER-Regulated Biological Product Manufacturers,” which takes effect 5/14, provides a long-awaited framework and clarifies how FDA will evaluate commercial readiness, application commitments, CGMP compliance, and data integrity for both 351(a) and 351(k) BLAs. That’s the conclusion of attorneys **Cathy Burgess** and **Yifan Wang** (Alston & Bird) in an online [post](https://www.alston.com/en/insights/publications/2026/05/fda-compliance-cder-regulated-biological-products?ref=fdaweb.com) analyzing the new compliance program.

Highlights of the program are:

- FDA will use a single inspection framework across standalone and biosimilar BLAs;
- inspections will be led by the Office of Pharmaceutical Quality and integrated into the BLA review process; and
- FDA will use a risk-based approach to determine when inspections or alternative tools are appropriate to support product approval.

The new compliance program distinguishes between pre-license inspections (PLIs) and pre-approval inspections (PAIs) this way, the attorneys say:

- a PLI is an inspection of a facility that manufactures a new biological product subject to an original BLA;
- a PAI is an inspection of a facility that manufactures a licensed biological product for which the applicant has submitted a supplement for a significant manufacturing change, such as a prior-approval supplement, that requires on-site review.

The attorneys say the new program describes a risk-based approach to determining whether a PLI or PAI is necessary, based on:

- the manufacturing operations described in the application;
- prior inspection history;
- prior assessment of the same or similar operations;
- product and process complexity; and
- quality signals.

FDA identifies two primary objectives for PLIs and PAIs, the post says:

- to evaluate and verify application commitments and compliance with applicable CGMP requirements; and
- to evaluate the integrity of the data associated with the application.

The attorneys recommend that BLA applicants submit a manufacturing schedule with the BLA and ensure consistency in inspection responses.