Regulatory Open Forum

Hi Pravin:

Doesn't the FDA Guidance document on "Nasal Spray and Inhalation Solution, Suspension, 
and Spray Drug Products" indicate labeling requirements for nebulizers?

See: https://www.fda.gov/files/drugs/published/Nasal-Spray-and-Inhalation-Solution--Suspension--and-Drug-Products.pdfhttps://www.fda.gov/files/drugs/published/Nasal-Spray-and-Inhalation-Solution--Suspension--and-Drug-Products.pdf

Best regards my friend,

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Thomas Navarro, RAC
Regulatory Project Manager
San Mateo, CA USA
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Original Message:
Sent: 07-Sep-2021 19:45
From: Pravin Soni
Subject: Aerosol delivery data on label of nebulizer product administered vis ventilator

Does anyone have a sense for what delivered dose (DD) and aerosol information the FDA will expect to have on the label of a product that would deliver drug using a nebulizer to mechanically ventilated patients?

 

Thanks

 

Pravin

No, that Guidance only covers hand-held nebulizers

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Pravin Soni
Sunnyvale CA
United States
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Original Message:
Sent: 08-Sep-2021 18:16
From: Thomas Navarro
Subject: Aerosol delivery data on label of nebulizer product administered vis ventilator

Hi Pravin:

Doesn't the FDA Guidance document on "Nasal Spray and Inhalation Solution, Suspension,
and Spray Drug Products" indicate labeling requirements for nebulizers?

See: https://www.fda.gov/files/drugs/published/Nasal-Spray-and-Inhalation-Solution--Suspension--and-Drug-Products.pdfhttps://www.fda.gov/files/drugs/published/Nasal-Spray-and-Inhalation-Solution--Suspension--and-Drug-Products.pdf

Best regards my friend,

------------------------------
Thomas Navarro, RAC
Regulatory Project Manager
San Mateo, CA USA

Original Message:
Sent: 07-Sep-2021 19:45
From: Pravin Soni
Subject: Aerosol delivery data on label of nebulizer product administered vis ventilator

Does anyone have a sense for what delivered dose (DD) and aerosol information the FDA will expect to have on the label of a product that would deliver drug using a nebulizer to mechanically ventilated patients?

 

Thanks

 

Pravin