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  1. Depending on the browser you are using, you may need to download the form to enable field fillable functionality. Use the following instructions to download the form if you encounter an...

  2. Learn how to fill out Form FDA 356h, which is required for submitting a new or abbreviated new drug or biologic for human use to the FDA. The form includes fields for applicant information, product description, application information, and submission type.

  3. Learn how to complete Form 356h, a required form for submitting a new drug, biologic, or antibiotic application to FDA. Download a fillable PDF of the form and user instructions.

  4. fda.report › media › 72649FORM FDA 356h

    Download the FDA 356h form to submit a new or abbreviated new drug or biologic for human use to the Food and Drug Administration. The form contains sections for applicant information, product description, application information, establishment information, and submission information.

  5. 30 sie 2023 · ICR 201804-0910-010. Form FDA 356h. ( Supplementary Document ) ⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0338 can be found here: 2024-09-19 - No material or nonsubstantive change to a currently approved collection. 2023-08-30 - Revision of a currently approved collection.

  6. To align with PDUFA VII , BsUFA III, and GDUFA III requirements as well as make other improvements to data quality and ease of use, FDA has revised form 356h: Application to Market a New or...

  7. Download Fillable Form Fda356h In Pdf - The Latest Version Applicable For 2024. Fill Out The Application To Market A New Or Abbreviated New Drug Or Biologic For Human Use Online And Print It Out For Free.

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