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1. www.fda.gov › media › 84223FORM FDA 356h SUPPLEMENT - U.S. Food and Drug Administration

   www.fda.gov › media › 84223

   INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE. (The field numbers below correspond to the numbered boxes on the...

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2. www.fda.gov › about-fda › reports-manuals-formsForms | FDA - U.S. Food and Drug Administration

   www.fda.gov › about-fda › reports-manuals-forms

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   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...

3. prnxggold.navitascloud.com › eCTDCompile › 987054DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No....

   prnxggold.navitascloud.com › eCTDCompile › 987054

   form fda 356h (08/18 - previous editions obsolete) page 2 of 29. Cross References (List related BLAs, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, MAFs, and DMFs referenced in the current application.)

4. www.templateroller.com › template › 1899231Form FDA356H - Fill Out, Sign Online and Download Fillable PDF

   www.templateroller.com › template › 1899231

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   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.

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

   fda.report › media › 72649

   Reset Form. DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0338. Food and Drug Administration Expiration Date: March 31, 2020. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW See PRA Statement on page 3. DRUG OR BIOLOGIC FOR HUMAN USE 1. Date of Submission (mm/dd/yyyy) (Title 21, Code of Federal Regulations, Parts 314 & 601 ...

6. www.accessdata.fda.gov › cder › eCTDRequired Forms - Food and Drug Administration

   www.accessdata.fda.gov › cder › eCTD

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   For guidance on Form 1571, and to download a fillable PDF, select this link. To apply to market a new drug, biologic, or an antibiotic drug for human use, you need to complete Form 356h....

7. www.fda.gov › about-fda › formsNew and Updated FDA Forms | FDA - U.S. Food and Drug...

   www.fda.gov › about-fda › forms

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   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...