PDUFA

FDA pushes back Gamida Cell’s PDUFA date by three months
Endpoints
Sun, 11/27/22 - 07:12 pm
Gamida Cell
PDUFA
FDA
omidubicel
November will bring political change. Will it also change drug prices and PDUFA?
MedCity News
Thu, 06/16/22 - 10:24 am
politics
drug pricing
PDUFA
elections
FDA releases PDUFA VI program report on combination products
Endpoints
Tue, 09/1/20 - 10:39 am
FDA
PDUFA
PDUFA meeting airs industry's take on FDA communications
RAPS.org
Wed, 08/19/20 - 09:29 am
FDA
PDUFA
regulatory
GAO Analysis Says FDA is Meeting PDUFA Commitments
FDA Law Blog
Wed, 04/8/20 - 11:43 pm
FDA
GAO
PDUFA
FDA to meet PDUFA goals despite government shutdown bolus
BioCentury
Mon, 02/18/19 - 07:36 pm
FDA
PDUFA
government shutdown
The FDA just unveiled its new, pricier fee schedule to review new drugs
Endpoints
Fri, 09/15/17 - 09:15 am
FDA
user fees
PDUFA
FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018
RAPS.org
Thu, 09/14/17 - 10:28 am
FDA
PDUFA
BsUFA
user fees
BioMarin says the FDA game clock now ticking on their blockbuster hopeful pegvaliase
Endpoints
Wed, 08/30/17 - 10:01 am
Biomarin
FDA
pegvaliase
PDUFA
With Kite’s PDUFA date looming, federal court tosses Juno’s CAR-T patent challenge — for now
Endpoints
Wed, 06/14/17 - 11:43 am
Kite Pharma
PDUFA
CAR-T
patents
Juno Therapeutics
KTE-C19
PDUFA amendment would broaden off-label rules
Medical Marketing and Media
Wed, 06/7/17 - 11:24 am
FDA
PDUFA
off-label
drug marketing
The FDA Missed Egalet's PDUFA Date, But Investors Should Not Be Worried
Yahoo/Benzinga
Sat, 10/15/16 - 12:36 pm
FDA
Egalet
PDUFA
Arymo ER
PDUFA 6 procedures will include patients, biomarkers for 2018-2022
BioPharma Dive
Mon, 07/18/16 - 11:04 am
FDA
PDUFA
patients
biomarkers
FDA Revises Formal Meetings Guidance for PDUFA Products
FDA Law Blog
Tue, 04/7/15 - 09:53 am
FDA
PDUFA
Measure to increase FDA funds through new company fees goes to Obama
Washington Post, DC
Wed, 06/27/12 - 10:44 am
PDUFA
Obama
healthcare reform
FDA Panel Conflict Rules Loosened By PDUFA
Pharmalot
Wed, 06/20/12 - 12:29 pm
PDUFA
FDA
advisory panels
The House PDUFA Bill Would Do What?
Pharmalot
Tue, 05/29/12 - 05:10 pm
congress
FDA
PDUFA
U.S. Senate passes bipartisan FDA funding bill
Reuters
Fri, 05/25/12 - 10:01 am
Senate
FDA
PDUFA
As The Senate Vote On PDUFA Finally Nears…
Pharmalot
Thu, 05/24/12 - 12:54 pm
Senate
PDUFA
drug approvals
FDA
biosimilars
Cytomedix: A Little-Known Biotech With Big, PDUFA-Type Decision Coming Up
Seeking Alpha
Tue, 05/1/12 - 11:28 am
PDUFA
Cytomedix
wound care
Angiogenesis

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