PDUFA VII

FDA elevates OTAT to “Super Office” within CBER
RAPS.org
Mon, 10/3/22 - 10:08 am
regulatory
FDA
OTAT
CBER
PDUFA VII
FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)
FDA Law Blog
Fri, 10/8/21 - 10:38 am
regulatory
FDA
post-marketing studies
PDUFA VII
PDUFA VII is a step in the right direction for the rare disease community
RAPS.org
Tue, 09/7/21 - 10:51 pm
FDA
regulatory
PDUFA VII
Rare Diseases
Industry lauds PDUFA VII focus on innovation, transparency
RAPS.org
Thu, 08/26/21 - 08:46 pm
PDUFA VII
innovation
regulatory
transparency
FDA
PDUVA VII commitment letter: RWE, rare diseases see renewed attention
RAPS.org
Mon, 08/23/21 - 11:20 pm
FDA
regulatory
PDUFA VII
RWE
real world evidence
Industry, FDA begin to hammer out PDUFA VII details
Endpoints
Fri, 01/15/21 - 09:56 am
FDA
PDUFA VII
5 questions facing the FDA in 2021
BioPharma Dive
Thu, 01/14/21 - 10:40 am
FDA
Joe Biden
COVID-19
pandemic
PDUFA VII
clinical trials