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
Global regulators issue call for clinical trial data transparency
RAPS.org
Sun, 05/9/21 - 10:55 pm
clinical trials
clinical trial transparency
regulatory
CDER regulatory science division touts 2020 accomplishments
RAPS.org
Mon, 05/3/21 - 10:59 pm
FDA
CDER
regulatory
FDA scraps another last-minute Trump-era policy
RAPS.org
Sat, 05/1/21 - 09:17 pm
FDA
regulatory
NDAs
ANDAs
Biden administration will allow nearly all providers to prescribe buprenorphine
Stat
Tue, 04/27/21 - 11:01 am
Joe Biden
opioids
opioid crisis
opioid addiction
buprenorphine
regulatory
New laws address NCE exclusivity, biosimilar education
RAPS.org
Mon, 04/26/21 - 10:59 pm
Joe Biden
legislative
regulatory
biosimilars
NCE
FDA walks back Trump-era premarket notification exemptions
RAPS.org
Fri, 04/16/21 - 12:04 am
FDA
regulatory
premarket notification pathway
3 changes coming to drug pricing
MedCity News
Tue, 04/13/21 - 10:22 am
drug pricing
regulatory
Drugmakers suggest tweaks to FDA’s neurodegenerative disease gene therapy guidance
RAPS.org
Wed, 04/7/21 - 10:20 am
regulatory
FDA
Health Canada
neurodegenerative disease
Special Counsel raises questions about FDA’s biologics inspections
RAPS.org
Thu, 04/1/21 - 10:56 am
FDA
biologics
regulatory inspections
regulatory
Why Surface Oncology Is Flying Higher After Hours Today
Motley Fool
Tue, 03/30/21 - 10:17 pm
Surface Oncology
FDA
cancer
regulatory
FDA's No. 2 Amy Abernethy to leave the agency in April
Endpoints
Tue, 03/23/21 - 10:57 am
FDA
regulatory
Amy Abernethy
Baxter, digital health startups lead pushback against 510(k) exemptions
BioPharma Dive
Tue, 03/23/21 - 10:55 am
devices
Baxter
FDA
510(k)
regulatory
digital health
HHS hits pause on Trump era SUNSET rule
RAPS.org
Mon, 03/22/21 - 09:52 pm
HHS
Sunset rule
regulatory
FDA’s inspection backlog: GAO raises concerns as delays mount
RAPS.org
Tue, 03/9/21 - 09:45 pm
FDA
GAO
inspections
regulatory
FDA calls for stakeholders to join MDUFA talks
RAPS.org
Thu, 02/18/21 - 09:56 pm
FDA
devices
regulatory
MDUFA
patient advocacy groups
The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
Drug Patent Watch
Wed, 02/3/21 - 10:52 pm
regulatory
biosimilars
Europe
EMA
FDA
FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients
RAPS.org
Thu, 01/28/21 - 11:21 pm
FDA
clinical trials
pandemic
COVID-19
regulatory
Emergency Use Authorization

Pages