regulatory

FDA relaxes EUA advertising limitation for some COVID drugs
RAPS.org
Wed, 11/16/22 - 11:20 pm
FDA
COVID-19
pharma advertising
regulatory
FDA finalizes umbrella trial guidance for cell and gene therapies
RAPS.org
Sun, 11/6/22 - 01:28 pm
FDA
regulatory
clinical trials
umbrella trials
gene therapy
cell therapy
FDA still not ready to go back to actual in-person meetings with biopharma sponsors
Endpoints
Thu, 11/3/22 - 07:22 pm
FDA
regulatory
COVID-19
pandemic
Sponsors need to maintain robust oversight of CROs to avoid FDA enforcement action
RAPS.org
Thu, 11/3/22 - 07:19 pm
FDA
regulatory
CROs
This Week at FDA: Califf considering diagnostic reform rulemaking, Ashley says goodbye
RAPS.org
Sun, 10/30/22 - 04:20 pm
FDA
regulatory
Robert Califf
diagnostics
Medtech
UK Medical Device Regulations Delayed for 1 Year
Medical Devices and Diagnostics Industry
Wed, 10/26/22 - 06:43 pm
UK
devices
regulatory
Medtech
FDA proposes breakthrough status for devices that address health disparities
RAPS.org
Sun, 10/23/22 - 07:05 pm
FDA
CDRH
breakthrough device
regulatory
FDA finalizes multiple endpoints guidance
RAPS.org
Fri, 10/21/22 - 11:05 am
FDA
regulatory
clinical trials
multiple endpoints
Pharma industry making some headway in DSCSA implementation
RAPS.org
Tue, 10/18/22 - 10:04 pm
DSCSA
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

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