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regulatory
This Week at FDA: Former FDA commissioners push for reforms cut from user fee package
RAPS.org
Sun, 10/16/22 - 05:15 pm
regulatory
FDA
user fees
Scott Gottlieb
Mark McClellan
Study highlights lack of transparency in FDA’s regulatory safety actions
RAPS.org
Thu, 10/13/22 - 09:15 am
FDA
regulatory
transparency
FDA finalizes guidances on device post-approval studies, postmarket surveillance
RAPS.org
Tue, 10/11/22 - 10:37 am
FDA
regulatory
devices
Medtech
post-approval studies
postmarketing studies
FDA posts FY2023 user fee tables
RAPS.org
Thu, 10/6/22 - 07:10 pm
FDA
regulatory
user fees
FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III
RAPS.org
Thu, 10/6/22 - 10:49 am
regulatory
FDA
generics
GDUFA
FDA elevates OTAT to “Super Office” within CBER
RAPS.org
Mon, 10/3/22 - 10:08 am
regulatory
FDA
OTAT
CBER
PDUFA VII
Federal watchdog highlights flaws in speedy FDA approvals
BioPharma Dive
Sun, 10/2/22 - 07:48 pm
FDA
regulatory
accelerated approvals
'Practically clean' FDA user fees reauth will be included in spending bill wrapping up next week
Endpoints
Thu, 09/22/22 - 11:51 pm
FDA
regulatory
user fees
legislation
Industry seeks clarity on FDA’s standards recognition process for regenerative medicines
RAPS.org
Wed, 09/21/22 - 07:59 pm
FDA
regulatory
regenerative medicine
FDA issues final rule on ‘right to try’ reporting requirements
RAPS.org
Thu, 09/15/22 - 10:23 am
regulatory
FDA
Right to Try Act
Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring
RAPS.org
Wed, 09/14/22 - 08:12 pm
FDA
regulatory
CBER
vaccines
COVID-19
remote inspections
Congress hits home stretch renewing FDA user fee programs
Axios
Wed, 09/14/22 - 08:02 pm
FDA
regulatory
user fees
Nearly one in five regulatory professionals changed jobs in 2021, new report shows
RAPS.org
Tue, 09/13/22 - 10:37 am
regulatory
Pharma groups: FDA should allow portals, emails for tracing products under DSCSA
RAPS.org
Thu, 09/8/22 - 04:36 pm
FDA
regulatory
supply chain
Pharma groups: FDA is exceeding its authority in risk management plan guidance
RAPS.org
Thu, 09/1/22 - 08:00 pm
regulatory
FDA
risk managmenet plans
APIs
Decentralized regulation: What do FDA remote assessments mean for sponsors?
Clinical Trials Arena
Wed, 08/31/22 - 10:34 am
regulatory
FDA
RRA
remote regulatory assessments
FDA Opens Review Into Opioid Prescribing, Warning Regulations
RAPS.org
Tue, 08/30/22 - 06:30 pm
FDA
regulatory
opioids
opioid crisis
Stakeholders ask FDA to be more flexible on rescinding breakthrough drugs designations
RAPS.org
Sun, 08/28/22 - 10:17 pm
FDA
regulatory
breakthrough therapies
FDA’s adcomm process needs reform, researchers say
RAPS.org
Mon, 08/22/22 - 08:17 pm
FDA
regulatory
advisory panels
transparency
Study: Most accelerated approval indications don’t add high therapeutic value
RAPS.org
Sun, 08/21/22 - 09:45 pm
regulatory
accelerated approvals
Europe
FDA
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