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Office of Hematology Oncology Products (OHOP) Reorganization: Information for IND, NDA and BLA Sponsors


In some cases, this reorganization requires reassignment of current INDs, NDAs and BLAs to the newly organized DOP1 and DOP2 (reassignment based on indication/division) and reassignment of applications to DHP (for hematology products). 

A. Transfer of Applications

Applications Moving to DHP
This list includes hematology applications that will be moving from the former Division of Drug Oncology Products (DDOP) and/or Division of Biologic Oncology Products (DBOP) to Division of Hematology Products (DHP).

Applications Moving to DOP1
This list includes solid tumor and supportive care applications that will be moving from the former Division of Biologic Oncology Products (DBOP) to the new Division of Oncology Products 1 (DOP1).

Applications Moving to DOP2
This list includes solid tumor applications that will be moving from the former Division of Drug Oncology Products (DDOP) to the new Division of Oncology Products 2 (DOP2).


If you believe your application number is listed in error and should not be transferred, or was omitted in error and should be transferred, please contact the appropriate individual(s) listed below:

Division of Hematology Products (DHP) for applications listed under DHP: Janet Jamison at 301-796-2313 or Ebla Ali Ibrahim at 301-796-3691.

Division of Oncology Products 1 (DOP1) for applications listed under DOP1: Frank Cross at 301-796-0876 or Alice Kacuba at 301-796-1381.

Division of Oncology Products 2 (DOP2) for applications listed under DOP2: Karen Jones at 301-796-1377.

  1. Applications that resided in the former DDOP that are not listed will reside in the new DOP1.
  2. Applications that resided in the former DBOP that are not listed will reside in the new DOP2.
  3. Applications that resided in DHP that are not listed will reside in DHP.

B. Scheduled Meetings

Sponsor meetings that are already scheduled will occur with the existing division and review team as scheduled unless otherwise directed.  If necessary and if not already transferred, after the meeting a decision will be made regarding whether the application should be transferred to another division.

C. Application Logistics

New NDAs, Original BLAs and supplements:

New NDAs, original BLAs and supplements should be submitted to the division (i.e., addressed to the appropriate Division Director) responsible for reviewing the indication unless otherwise directed.

Applications with Pending Actions:

Applications (e.g., INDs, NDAs, BLAs, efficacy and labeling supplements) with pending actions (i.e., during 30-day IND safety review and marketing applications currently under review), will be reviewed by the existing review team until regulatory action is taken unless otherwise directed.  After regulatory action is taken (e.g., Study(ies) may proceed, clinical hold for INDs or Approval, Complete Response for NDAs, BLAs, and supplements), a decision will be made whether the application will remain in the same division or whether it will be transferred to another division.

D. New Pre-IND Meeting Requests and New IND Submissions

Existing INDs with Multiple Indications that will be Reviewed in More Than One Division

As a result of an indication-specific review structure, sponsors of existing INDs which currently contain multiple indications that will be reviewed in more than one division will should submit new INDs when the sponsor determines that a specific indication for a drug will be developed (usually in the later stages of drug development, for example, around or at end of phase 2).  Note that the IND would not need to be administratively split if a determination has not been made to develop the drug for a specific tumor type.

When submitting a new IND in order to administratively split the indications from the existing IND, please do the following:

  • In the cover letter subject line prominently identify the submission as: “IND ADMINISTRATIVE SPLIT FROM EXISTING IND. NEW IND PROPOSED INDICATION [INSERT INDICATION]”.
  • Submit FDA form 1571 identifying the specific indication being studied. 
  • Nonclinical and CMC information may be cross-referenced to the existing IND.
  • This letter should be submitted to the division (i.e., addressed to the appropriate Division Director) responsible for reviewing the indication with a cross reference to the existing IND.

New Pre-IND Meeting Requests and New INDs for IDENTIFIED INDICATION[S]

If you plan to develop a drug in a specific indication, you should submit your Pre-IND meeting request or new IND to the division (i.e., addressed to the appropriate Division Director) responsible for reviewing the indication.  Going forward, OHOP will request new INDs for each primary tumor site being studied.

In the cover letter subject line of your Pre-IND Meeting request or new IND, prominently identify the submission and proposed indication as:

“Pre-IND MEETING REQUEST PROPOSED INDICATION [INSERT INDICATION]” or
“NEW IND PROPOSED INDICATION [INSERT INDICATION]”. 

New Pre-IND Meeting Requests and New INDs for SOLID TUMORS WHERE A SPECIFIC INDICATION FOR DRUG DEVELOPMENT HAS NOT BEEN IDENTIFIED

Sponsors typically have a general idea regarding the tumor types the drug is planned to be developed even during early phases of drug development.  Therefore, in the cover letter subject line of your submission, prominently identify the submission and proposed indication(s) as:

“Pre-IND MEETING REQUEST: SPECIFIC INDICATION NOT IDENTIFIED. SEVERAL TUMOR TYPES: [INSERT INDICATION(S)]”
or
“NEW IND: SPECIFIC INDICATION NOT IDENTIFIED. SEVERAL TUMOR TYPES: [INSERT INDICATIONS]”.   

Direct your submission to the division (i.e., addressed to the appropriate Division Director) responsible for reviewing the indication or the division that is responsible for reviewing the majority of the indications that you are planning to develop.  In rare situations where no specific tumor type is being studied (e.g., patients with solid tumors and advanced hematologic malignancies), OHOP will assign the review division.

General Information Regarding Submission of New INDs with Previous Pre-IND Meetings

If a Pre-IND meeting has already occurred, the new IND should be submitted to the division (i.e., addressed to the appropriate Division Director) responsible for reviewing the indication. If you are uncertain which Division will review the new IND, please consult with the RPM of the division which held the Pre-IND meeting to see where the new IND should be submitted.