regulatory

The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use Regulation
FDA Law Blog
Sun, 08/15/21 - 11:10 pm
FDA
intended use
regulatory
FDA new drug applications to cost more than $3M in 2022
Beckers Hospital Review
Sat, 08/14/21 - 01:53 pm
FDA
NDAs
regulatory
Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices
Endpoints
Fri, 08/6/21 - 12:17 pm
FDA
devices
drug-device combos
regulatory
FDA finalizes long-awaited intended use rule
RAPS.org
Mon, 08/2/21 - 09:51 pm
FDA
regulatory
intended use
FDA sends 2nd noncompliance notice for company failing to post trial results as crackdown ramps up
Endpoints
Fri, 07/30/21 - 11:11 am
FDA
regulatory
clinical trials
Accuitis
House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites
Endpoints
Mon, 07/26/21 - 10:15 pm
FDA
regulatory
foreign inspections
regulatory inspections
Woodcock: FDA needs expanded authority on device shortages
RAPS.org
Thu, 07/22/21 - 10:09 pm
FDA
regulatory
devices
Janet Woodcock
device shortages
FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+
Endpoints
Mon, 07/19/21 - 11:07 am
FDA
regulatory
regulatory inspections
Janet Woodcock
Too close for comfort: FDA shouldn’t loosen conflict rules for its expert panels
Stat
Mon, 07/19/21 - 10:46 am
FDA
expert panels
regulatory
Patient experience data in regulatory decisions: Questions abound in first FDA report
Endpoints
Wed, 06/30/21 - 11:13 am
FDA
regulatory
patients
patient experience data
drug approvals
Shuren: Time to rethink FDA's device regulatory framework
RAPS.org
Wed, 06/23/21 - 10:41 pm
devices
FDA
regulatory
FDA launches global Generic Drug Cluster
RAPS.org
Mon, 06/14/21 - 11:59 pm
FDA
generics
regulatory
FDA disappointed with slow uptake of approvals for stem cell therapies
RAPS.org
Wed, 06/9/21 - 10:53 pm
FDA
regulatory
stem cells
FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages
RAPS.org
Tue, 06/8/21 - 09:46 pm
FDA
pandemic
devices
regulatory
Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections
Pharma Tech
Thu, 05/27/21 - 12:00 am
FDA
inspections
regulatory
COVID-19
pandemic
When FDA Makes You An Offer You Can’t Refuse
FDA Law Blog
Wed, 05/26/21 - 12:02 am
FDA
regulatory
drug approvals
CDER
DRG
Acceleron, under threat of fines, reports out a negative study
RAPS.org
Wed, 05/26/21 - 12:00 am
Acceleron
clinical trials
regulatory
FDA may decline new COVID vaccine EUA requests
RAPS.org
Tue, 05/25/21 - 11:55 pm
FDA
regulatory
COVID-19
vaccines
Emergency Use Authorization
FDA releases batch of 21 product-specific guidances
RAPS.org
Wed, 05/19/21 - 11:21 pm
FDA
regulatory
generics
FDA issues new COVID-19 master protocol guidance
RAPS.org
Mon, 05/17/21 - 10:55 pm
FDA
regulatory
drug development
COVID-19

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