regulatory

FDA clarifies rules around drug importation from Canada
Beckers Hospital Review
Wed, 06/1/22 - 09:51 am
FDA
regulatory
Canada
drug importation
Pile-on over PBMs continues with FTC comments and a new bipartisan Senate bill
Endpoints
Thu, 05/26/22 - 10:48 pm
FTC
PBMs
regulatory
Senate
Medtech groups want more time to implement FDA’s QMSR rule
RAPS.org
Wed, 05/25/22 - 11:43 pm
devices
Medtech
FDA
QMSR
regulatory
What FDA’s New Machine Learning Guiding Principles Really Mean
Medical Devices and Diagnostics Industry
Mon, 05/23/22 - 06:49 pm
FDA
regulatory
machine learning
artificial intelligence
Califf uses budget hearing to advocate for resources, authority to monitor supply chains
RAPS.org
Fri, 05/20/22 - 10:17 am
Robert Califf
FDA
infant formula
regulatory
supply chain
FDA explains plans to bolster cell and gene therapy approvals through wider messaging
RAPS.org
Thu, 05/19/22 - 09:01 pm
FDA
regulatory
cell therapy
gene therapy
FDA commissioner announces new role for Janet Woodcock, downshifting away from drugs
Endpoints
Thu, 05/19/22 - 10:22 am
FDA
Janet Woodcock
Robert Califf
regulatory
User fee reauthorization bill advances in the House, Senate eyes different riders
RAPS.org
Wed, 05/18/22 - 11:57 pm
regulatory
FDA
user fees
FDA to create training program to inspect more mRNA vaccine manufacturing
Endpoints
Fri, 05/6/22 - 10:49 am
FDA
MRNA
training
regulatory
FDA's use of adcomms prior to drug approval decreased over the last decade
RAPS.org
Tue, 05/3/22 - 10:49 pm
FDA
regulatory
advisory panels
drug approvals
FDA guidance machine churns out 8 new documents in less than a week
Endpoints
Mon, 05/2/22 - 06:17 pm
FDA
regulatory
ulcerative colitis
Crohn's Disease
cancer
clinical trials
Burr chastises FDA at second Senate user fee hearing
RAPS.org
Wed, 04/27/22 - 10:41 am
regulatory
devices
MDUFA
FDA
Medtech
FDA officials: Firms with strong quality cultures more resilient to data integrity problems
RAPS.org
Tue, 04/26/22 - 10:35 pm
FDA
data
regulatory
data integrity
FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results
Endpoints
Mon, 04/25/22 - 10:46 am
FDA
regulatory
clinical trials
Ocugen
vaccines
COVID-19
Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome
RAPS.org
Wed, 04/20/22 - 11:27 pm
FDA
Medtech
regulatory
devices
device shortages
FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors
BioSpace
Wed, 04/20/22 - 11:19 pm
FDA
regulatory
cancer
PI3k inhibitor
As FDA offers breakthrough designation to device makers, patients and providers are left with questions
Stat
Mon, 04/18/22 - 10:51 am
devices
Medtech
FDA
regulatory
breakthrough device
Is biopharma getting better at accelerated approval conversions?
EP Vantage
Mon, 04/18/22 - 10:37 am
FDA
CDER
accelerated approvals
regulatory
FDA eases review burden for certain sutures, orthopedic devices in leap-frog guidances
RAPS.org
Mon, 04/11/22 - 07:29 pm
FDA
devices
Medtech
regulatory
Orthopedic
FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence'
Fierce Biotech
Mon, 04/11/22 - 10:41 am
Robert Califf
FDA
accelerated approvals
regulatory

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