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FDA 356h Application to Market a New Drug or Abbreviated New Drug
Biologics License Applications; Procedures & Requirements
Form FDA 356h with comments noting changes Aug 2022
Biologics; Licensing; General Biological Products Standards; and Additional Standards
OMB: 0910-0338
OMB.report
HHS/FDA
OMB 0910-0338
ICR 202302-0910-011
IC 5935
FDA 356h Application to Market a New Drug or Abbreviated New Drug
( )
⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0338 can be found here:
2023-08-30 - Revision of a currently approved collection
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