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regulatory
Aurobindo warned for lax investigations, repeat GMP violations
RAPS.org
Thu, 01/27/22 - 10:46 am
regulatory
FDA
Aurobindo
drug manufacturing
FDA's domestic inspection hold will continue until February
Endpoints
Mon, 01/24/22 - 10:13 am
FDA
regulatory
regulatory inspections
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
RAPS.org
Fri, 01/21/22 - 11:01 am
FDA
regulatory
clinical trials
clinical trial diversity
generics
FDA misses MDUFA V deadline after months of contentious talks
Medtech Dive
Wed, 01/19/22 - 11:17 pm
FDA
devices
MDUFA
MDUVA V
regulatory
FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care
FDA Law Blog
Tue, 01/18/22 - 10:23 am
FDA
regulatory
3D printing
devices
Medtech
Former commissioners, Woodcock dissect pandemic response, future challenges at FDA
RAPS.org
Tue, 01/18/22 - 10:18 am
FDA
Janet Woodcock
pandemic
COVID-19
regulatory
5 questions facing the FDA in 2022
BioPharma Dive
Tue, 01/11/22 - 10:20 pm
FDA
regulatory
Robert Califf
Biogen
Aduhelm
FDA pauses domestic drug inspections again, this time to protect against Omicron
Endpoints
Wed, 01/5/22 - 10:36 am
FDA
inspections
regulatory
COVID-19
Omicron COVID-19 variant
Robert Califf is a fervent believer in data. At the FDA, will that be enough?
Stat
Wed, 01/5/22 - 10:31 am
FDA
Robert Califf
regulatory
Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending
RAPS.org
Mon, 12/6/21 - 11:44 pm
regulatory
accelerated approvals
Medicare
FDA expands eSTAR filing to de novo devices, IVDs
RAPS.org
Thu, 12/2/21 - 10:56 pm
devices
FDA
regulatory
de novo pathway
eSTAR
Who Would Be the Best FDA Commissioner for Biotech Investors?
Motley Fool
Sun, 11/28/21 - 10:48 pm
FDA
regulatory
Robert Califf
Janet Woodcock
New drug applications pile up with delays as there's no easy fix for the inspection backlog
Endpoints
Tue, 11/23/21 - 09:52 am
FDA
regulatory
inspections
pandemic
COVID-19
FDA shakes up hepatitis C testing market by opening up 510(k) pathway
Medtech Dive
Mon, 11/22/21 - 10:30 am
FDA
regulatory
diagnostics
hepatitis C
510(k)
Does biopharma support the Califf nom for FDA? Yeah, whatever
Endpoints
Wed, 11/17/21 - 10:31 am
FDA
regulatory
Robert Califf
5 things to know about FDA chief nominee Dr. Robert Califf
Beckers Hospital Review
Mon, 11/15/21 - 11:53 pm
FDA
regulatory
Robert Califf
CPhI: As Covid-19 restrictions ease, an inspection backlog could have a big effect on new drugs, generics
Endpoints
Thu, 11/11/21 - 11:09 am
CPhI
pandemic
FDA
regulatory
COVID-19
inspections
generics
Congress must regulate medical device repair to protect patients
MedCity News
Thu, 11/11/21 - 10:56 am
congress
regulatory
devices
Medtech
patients
Tracking the FDA's meeting on Pfizer's vaccine for kids
BioPharma Dive
Tue, 10/26/21 - 10:38 am
FDA
regulatory
Pfizer
BioNTech
vaccines
COVID-19
pediatric
FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule
FDA Law Blog
Mon, 10/25/21 - 11:58 pm
FDA
regulatory
de novo pathway
devices
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