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U.S. Department of Health and Human Services

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Realignment of Current INDs, NDAs and BLAs

 

Office of New Drugs Realignment: Applications
Realignment of current INDs, NDAs and BLAs

 

DAIOP has been renamed the Division of Anti-Infective Products (DAIP).  This newly named division will oversee the regulation of all antimicrobials, with the exception of antivirals and certain topical products.  Antimicrobial products and review staff reviewing antimicrobial products assigned to the DSPTP are being transferred to DAIP.

 

This list includes antimicrobial products that will be transferred from the Division of Special Pathogen and Transplant Products to the new Division of Anti-Infective Products. Transplant products residing in the Division of Special Pathogen and Transplant Products will remain in the new Division of Transplant and Ophthalmology Products.
 

DSPTP has been renamed the Division of Transplant and Ophthalmology Products (DTOP).  This newly renamed division will oversee the regulation of solid organ transplant and ophthalmology products.  Ophthalmology products and review staff reviewing ophthalmology products assigned to DAIOP are being transferred to DTOP.

 

This list includes ophthalmology products that will be transferred from the Division of Anti-Infective and Ophthalmology Products to the new Division of Transplant and Ophthalmology Products. Anti-Infective products residing in the Division of Anti-Infective and Ophthalmology Products will remain in the new Division of Anti-Infective Products.

The Division of Antiviral Products (DAVP) will remain unchanged.

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 listed below:

 

Division of Anti-Infective Products: Maureen Dillon-Parker (301-796-0706) or Frances LeSane (301-796-0747)

Division of Transplant and Ophthalmology Products: Diana Willard (301-796-0833) or Judit Milstein (301-796-0763)