regulatory

FDA outlines risk-based approach to monitoring clinical trials
RAPS.org
Tue, 04/11/23 - 07:19 pm
clinical trials
regulatory
FDA
risk
Study: Half of confirmatory studies for accelerated approvals are late
RAPS.org
Tue, 04/4/23 - 11:20 pm
JAMA
regulatory
accelerated approvals
FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval
Fierce Biotech
Mon, 03/27/23 - 10:14 am
FDA
oncology
regulatory
FDA outlines plan for digital health technologies for clinical trials
RAPS.org
Sun, 03/26/23 - 11:15 pm
FDA
regulatory
clinical trials
digital health
FDA will phase out 22 Covid-19 guidance documents as emergency declaration expires
Endpoints
Sun, 03/12/23 - 09:52 pm
COVID-19
regulatory
FDA
Researchers call on FDA to get tough on accelerated approval labeling
RAPS.org
Mon, 03/6/23 - 11:19 pm
FDA
regulatory
accelerated approval
Woodcock: Pending ORA reorg will “modify things significantly” for all FDA regulated products
RAPS.org
Sun, 03/5/23 - 03:13 pm
FDA
ORA
regulatory
Janet Woodcock
FDA has new leverage over companies looking for a quicker drug approval
NPR
Fri, 03/3/23 - 10:06 am
FDA
regulatory
accelerated approvals
drug approvals
FDA seeks feedback on artificial intelligence in drug manufacturing
RAPS.org
Wed, 03/1/23 - 06:53 pm
regulatory
FDA
artificial intelligence
drug manufacturing
FDA plans to launch communications pilot for promising rare disease gene therapies
RAPS.org
Mon, 02/27/23 - 07:10 pm
FDA
biologics
gene therapy
Rare Diseases
regulatory
PhRMA official discusses legislative priorities, lessons from the pandemic
RAPS.org
Fri, 02/24/23 - 08:36 am
PhRMA
legislation
pandemic
COVID-19
regulatory
UK could allow reciprocal drug approvals with US FDA as soon as 2024
Endpoints
Thu, 02/16/23 - 04:52 pm
regulatory
drug approvals
FDA
UK
Study: Extrapolation used in more than half of pediatric drug labeling changes
RAPS.org
Wed, 02/15/23 - 10:50 am
regulatory
pediatric
extrapolation
labeling
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
RAPS.org
Mon, 02/6/23 - 10:34 am
FDA
regulatory
regulatory inspections
Paxlovid
Jesduvroq
GSK
Pfizer
FDA to resume in-person formal meetings in February
RAPS.org
Mon, 01/30/23 - 05:54 pm
FDA
regulatory
pandemic
COVID-19
This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more
RAPS.org
Sun, 01/22/23 - 01:00 pm
FDA
regulatory
clinical trials
clinicaltrials.gov
Eli Lilly
donanemab
Medtronic
BeiGene
Seagen
FDA details approach for finding optimal dosages for new cancer drugs
RAPS.org
Wed, 01/18/23 - 10:42 am
FDA
oncology
cancer
regulatory
Expert: Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers
RAPS.org
Tue, 01/17/23 - 10:53 pm
devices
Medtech
device recalls
FDA
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

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