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Re: justdafactss post# 196559

Monday, 12/13/2021 9:31:15 AM

Monday, December 13, 2021 9:31:15 AM

Post# of 232092
Interesting on wanting to know what specific date the HIV-1 BLA (BLA 761144) was submitted....seems that a certain individual is also curious....

https://www.fda.gov/media/154586/download

This is from the "November 2021 FDA FOIA Closed Logs" which are FOIA requests submitted to the FDA that were completed and the reason they were closed. "Withdrawn Closed w/o Charges" means that the requestor withdrew their request and was not charged any fees by the FDA in the process of fulfilling the request.

So, what's a "Form FDA 356h" everyone asks?

FDA 356h form is the application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use. Applicant who want to submit BLA or NDA to USFDA need to file in the 356h form.


https://nckpharma.com/what-is-usfda-form-356h/

So, inquiring minds want to know...did the FDA say it was going to take "55 years" to respond? Or, was the FDA going to charge more than $5.95 to fulfill the request?

Well?

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