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regulatory
Drug Development for Rare Diseases is Littered with Regulatory Roadblocks
BioSpace
Fri, 08/19/22 - 10:41 am
Rare Diseases
drug development
regulatory
KemPharm
Orphazyme
This Week at FDA: Amazon warning letter, ANDA amendments, and more
RAPS.org
Sun, 08/14/22 - 10:44 pm
FDA
regulatory
monkeypox
Jynneos
ANDAs
Amazon
devices
340B entities face increased challenges in a shifting regulatory and enforcement landscape
MedCity News
Thu, 08/11/22 - 11:23 pm
340B
regulatory
FDA announces plans to revamp national drug code
RAPS.org
Thu, 08/4/22 - 10:50 am
National Drug Code
regulatory
FDA
FDA to expand use of remote regulatory assessments beyond the pandemic
Medtech Dive
Mon, 07/25/22 - 10:42 am
FDA
regulatory
pandemic
remote regulatory assessments
Medtech
Biosimilar inspections still lagging as the FDA looks to clear its backlog
Endpoints
Fri, 07/22/22 - 10:11 am
biosimilars
FDA
regulatory
regulatory inspections
CBO finds Senate's FDA user fee bill will reduce the federal deficit by about $1.4B
Endpoints
Thu, 07/21/22 - 09:52 pm
FDA
regulatory
CBO
user fees
FDA rule would facilitate prescription-to-OTC switches but nix a third class of drugs
Stat
Tue, 07/12/22 - 11:37 pm
FDA
regulatory
OTC
Proposed legislation takes aim at prescription drug advertising
RAPS.org
Mon, 07/11/22 - 05:51 pm
FDA
legislation
pharma advertising
pharma ads
regulatory
Supreme Court Decision On EPA Could Have Implications For Other Regulatory Agencies, Like FDA
Forbes
Tue, 07/5/22 - 11:49 am
regulatory
Supreme Court
FDA
FDA adds some fresh senior leadership with new chief scientist, chief medical officer
Endpoints
Thu, 06/30/22 - 10:09 pm
FDA
regulatory
Senate HELP sends user fee reauthorization bill to floor vote
RAPS.org
Wed, 06/15/22 - 10:30 am
Senate
user fees
FDA
regulatory
Study: FDA approves new oncology drugs quicker than EMA
RAPS.org
Mon, 06/13/22 - 10:33 am
JAMA
regulatory
drug approvals
FDA
EMA
Europe
US House Votes to Give FDA More Power Over Accelerated Approvals
BioSpace
Sun, 06/12/22 - 08:21 pm
FDA
regulatory
accelerated approvals
legislation
House Passes FDA Package Reauthorizing Drug, Device User Fees
Bloomberg Law
Thu, 06/9/22 - 10:30 am
legislation
regulatory
FDA
user fees
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
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