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General

CDER(Center for Drug Evaluation and Research)

CDER is the FDA center that reviews human drugs, covering prescription, over-the-counter, and generic products plus most therapeutic biologics, while vaccines, blood products, and cell and gene therapies are reviewed by CBER.

Usage Examples

  • The CDER Office of New Drugs assigned the NDA to the oncology review division.
  • CDER convened an advisory committee to review the benefit-risk profile.
  • The sponsor's pre-NDA meeting with CDER established the pivotal trial design.

What is CDER (Center for Drug Evaluation and Research)?

CDER is the FDA center that reviews human drugs, covering prescription, over-the-counter, and generic products plus most therapeutic biologics, while vaccines, blood products, and cell and gene therapies are reviewed by CBER.

CDER exists because a regulator cannot re-run a sponsor's trials or re-make its batches; a regulator can only read what the sponsor files. FDA therefore concentrates human drug review in a single center. CDER's job is to decide, before a drug reaches patients, whether the submitted evidence shows a benefit that outweighs the risk in a defined population.

CDER covers human drugs across their full lifecycle: prescription and over-the-counter products, generics filed as ANDAs, and most therapeutic biologics, including monoclonal antibodies for in vivo use and most proteins intended for therapeutic use. CDER does not cover vaccines, blood and blood products, or cell and gene therapies, which remain with CBER, and does not cover medical devices, which go to CDRH.

CDER is encountered in practice as a sequence of filings and clocks, not as an institution. A sponsor opens an IND with CDER and may start dosing 30 days later absent a clinical hold, runs the program, then files an NDA or ANDA that CDER acts on within a 180-day initial review cycle, and keeps reporting serious unexpected adverse experiences to CDER after approval.

Not to be confused with

CBER
CBER reviews vaccines, blood and blood products, and cell and gene therapies, while CDER reviews small molecules and most therapeutic biologics. The split follows product category, not molecule size, so a large-molecule biologic is frequently a CDER product.
CDRH
CDRH is FDA's device center. A product regulated as a device goes to CDRH even when it treats the same condition as a CDER-regulated drug, so the center follows the product's regulatory classification, not the therapeutic area.
FDA
FDA is the agency; CDER is one center inside it. A drug "FDA approval" is issued through CDER, but FDA also acts through CBER, CDRH, and other centers, so "FDA said" and "CDER said" are not interchangeable in a regulatory record.
CDER review division
the division is the specific therapeutic-area team that actually reviews a submission. Correspondence is addressed to CDER, but meetings, information requests, and the action letter come from a named division, and that division's precedent is what binds a program.

CDER is a center, not a regulation, so the obligations below are the ones a sponsor owes CDER at each stage of a drug program.

What you must do

  1. 1Wait until 30 days after FDA receives the IND before beginning the clinical investigation, unless FDA notifies the sponsor that the investigations are subject to a clinical hold21 CFR 312.40
  2. 2Submit the NDA, and any supplement to an approved NDA, in the form and containing the information required for that particular submission21 CFR 314.50
  3. 3Track the initial review cycle: CDER reviews the NDA or ANDA and sends either an approval letter or a complete response letter within 180 days of receipt21 CFR 314.100
  4. 4Report every adverse drug experience that is both serious and unexpected, foreign or domestic, no later than 15 calendar days from the applicant's initial receipt of the information21 CFR 314.80
  5. 5Confirm center jurisdiction before filing, since CDER holds monoclonal antibodies for in vivo use and most proteins intended for therapeutic use, except those specifically assigned to CBERFDA CDER/CBER product jurisdiction

Common mistakes

  • Waiting for CDER to "approve" the IND before dosing

    CDER issues no approval letter for an IND. The investigation may proceed 30 days after FDA receives it unless a clinical hold is imposed, so a team waiting for an affirmative notice that never arrives burns a month of enrollment for nothing.

  • Reading the 180-day clock as an approval date

    21 CFR 314.100 gives CDER 180 days to send an approval letter or a complete response letter, not to put the product on the market. A complete response sends the applicant back into a new cycle, and a major amendment extends the existing one; program plans built on "approval in six months" routinely slip by a year.

  • Assuming a biologic routes to CBER by default

    since October 1, 2003, monoclonal antibodies for in vivo use and most therapeutic proteins sit with CDER. Building the development plan around CBER guidance, CBER precedent, and CBER meeting requests wastes the pre-submission meetings that set the pivotal trial design, and those slots are the scarcest resource in the program.

When This Matters

  • The CDER Office of New Drugs assigned the NDA to the oncology review division.
  • CDER convened an advisory committee to review the benefit-risk profile.
  • The sponsor's pre-NDA meeting with CDER established the pivotal trial design.

Frequently Asked Questions

CDER reviews small-molecule drugs and most therapeutic biologics, including monoclonal antibodies for in vivo use and most proteins intended for therapeutic use; CBER reviews vaccines, blood and blood products, and cell and gene therapies. FDA moved most therapeutic biologics from CBER to CDER on October 1, 2003, leaving those categories behind.

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