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NDAs
FDA new drug applications to cost more than $3M in 2022
Beckers Hospital Review
Sat, 08/14/21 - 01:53 pm
FDA
NDAs
regulatory
FDA scraps another last-minute Trump-era policy
RAPS.org
Sat, 05/1/21 - 09:17 pm
FDA
regulatory
NDAs
ANDAs
Gilead Sciences Submits New Drug Application for Remdesivir as a COVID-19 Treatment
Motley Fool
Mon, 08/10/20 - 11:09 pm
Gilead Sciences
FDA
Emergency Use Authorization
NDAs
antivirals
COVID-19
Veklury
Striking While the Iron is Hot: New NDA, BLA Filings Spike in Q1 of FY 2020
RAPS.org
Wed, 02/5/20 - 09:57 pm
FDA
NDAs
BLAs
Government spending bill tweak means 3 more NDAs will become BLAs, FDA says
Endpoints
Thu, 01/16/20 - 10:24 am
legislation
regulatory
biologics
NDAs
BLAs
FDA
FDA Seeks to Pull 4 NDAs After Companies Failed to Submit Annual Reports
RAPS.org
Sat, 11/16/19 - 12:00 am
FDA
regulatory
annual reports
NDAs
FDA Compiles List of NDAs Transitioning to BLAs Next March
RAPS.org
Tue, 09/24/19 - 07:08 pm
FDA
NDAs
BLAs