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356h

What is USFDA form 356h?

What is USFDA form 356h?

Posted on01 Oct 2017

Tags356h, USFDA form 356h

Comments0

FDA 356h form is the application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use. Applicant who want...

What is Biologic License Application

What is Biologic License Application (BLA)?

Posted on19 Oct 2015

Tags356h, Biologic License Application, Biological License Application, Biosimilar, BLA, Teva filled Biologics License Application for reslizumab, USFDA form 356h

Comments0

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who...

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