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regulatory
FDA opens TAP
RAPS.org
Wed, 01/4/23 - 09:28 am
FDA
TAP
regulatory
Medtech
devices
MDUFA
FDA sees boost in FY23 budget proposal but no diagnostics reform
RAPS.org
Tue, 12/20/22 - 11:56 pm
FDA
regulatory
diagnostics
What FDA might consider as delaying or denying an inspection: New guidance spells out the specifics
Endpoints
Mon, 12/19/22 - 10:15 pm
regulatory
FDA
inspections
Pharma wins changes in bill regarding FDA’s accelerated approval
Stat
Mon, 12/19/22 - 10:09 pm
legislation
regulatory
FDA
accelerated approvals
Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
Endpoints
Sun, 12/11/22 - 01:29 pm
Lupin
generics
regulatory
FDA
inspections
FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
RAPS.org
Thu, 12/8/22 - 11:21 pm
FDA
PD-1/L1 therapy
regulatory
FDA Class I device recall events ticked up in FY 2022
RAPS.org
Tue, 12/6/22 - 08:48 pm
Medtech
devices
FDA
Class I recall
regulatory
This Week at FDA: FDA approves first FMT product, upcoming mpox guidance, and more
RAPS.org
Sun, 12/4/22 - 01:29 pm
FDA
regulatory
mpox
Ferring Pharmaceuticals
microbiome
COVID-19
Eli Lilly
FDA looks to modeling and simulation tools to streamline product reviews
RAPS.org
Tue, 11/29/22 - 11:08 am
FDA
regulatory
simulation
product reviews
Pfizer CEO Bourla stung by UK's pharma marketing regulator over kids' COVID vax claims: report
Fierce Pharma
Mon, 11/28/22 - 10:14 am
Pfizer
COVID-19
vaccines
UK
Albert Bourla
Pharma CEOs
pharma marketing
regulatory
PMCPA
FDA official discusses benefits, challenges of remote inspections
RAPS.org
Sun, 11/20/22 - 12:38 pm
regulatory
FDA
remote inspections
regulatory inspections
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
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