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2020-01-21 FDA

Applications Affected by the Reorganization of the Office of New Drugs

The approved restructuring of the Office of New Drugs (OND) creates offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. As a result, the names of OND’s offices and divisions have changed. If there is a change in signatory or point of contact for applications currently under review, then sponsors will be notified. However, at the start of each phase, we encourage sponsors to search within the provided Excel file for applications currently under review that may be affected by the reorganization.

The target start dates for each phase are as follows:

Phase II: on or about November 4, 2019 - Applications originally assigned to the following responsible organization and are currently under review may be affected:

• The Division of Anti-Infective Products of the Office of Antimicrobial Products (OAP)

• The Division of Anti-Viral Products of OAP

• The Division of Oncology Products I & II of the Office of Hematology and Oncology Products (OHOP)

• The Division of Hematology Products of OHOP

• The Division of Neurology Products of the Office of Drug Evaluation (ODE) I

• The Division of Psychiatry Products of ODE I

• The Division of Anesthesia, Analgesia, and Addiction Products of ODE II

Phase III: on or about January 21, 2020 – Applications originally assigned to the following responsible organization and are currently under review may be affected:

• The Division of Nonprescription Drugs of ODE IV

• The Division of Transplant and Ophthalmology Products of OAP

• The Division of Medical Imaging Products of ODE IV

Phase IV: on or about February/March 2020 – Applications originally assigned to the following responsible organization and are currently under review may be affected:

• The Division of Cardiovascular and Renal Products of ODE I

• The Division of Hematology Products of OHOP

• The Division of Metabolism and Endocrinology Products of ODE II

• The Division of Bone, Reproductive, and Urologic Products of ODE III

• The Division of Transplant and Ophthalmology Products of OAP

• The Division of Pulmonary, Allergy, Rheumatology Products of ODE II

• The Division of Gastroenterology and Inborn Errors Products of ODE III

• The Division of Dermatology and Dental Products of ODE III

• The Division of Pediatrics and Maternal Health of ODE IV

Return to Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

【来源】
Applications Affected by the Reorganization of the Office of New Drugs

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