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regulatory
Congress questions FDA, industry over MDUFA V delays
Medtech Dive
Fri, 04/1/22 - 10:36 am
Medtech
devices
FDA
regulatory
MDUFA
SEC to propose new rules to rein in SPACs
Endpoints
Wed, 03/30/22 - 11:07 am
SEC
regulatory
SPACs
Stakeholders ask for more time to transition EUA devices, diagnostics
RAPS.org
Tue, 03/29/22 - 01:36 pm
FDA
regulatory
Emergency Use Authorizations
devices
diagnostics
Medtech
How Covid failed to derail the FDA
EP Vantage
Sun, 03/27/22 - 03:48 pm
COVID-19
FDA
regulatory
FDA seeks to streamline inactive ingredient database with industry input
RAPS.org
Mon, 03/21/22 - 10:34 pm
FDA
regulatory
inactive ingredients
Pharma trading partners have ‘significant’ work ahead of 2023 DSCSA deadline
RAPS.org
Mon, 03/21/22 - 10:21 pm
regulatory
DSCSA
drug manufacturing
Remote inspections prompt drop in data integrity citations in FY2021
RAPS.org
Sun, 03/13/22 - 11:00 pm
regulatory
remote inspections
FDA reaches MDUFA V agreement with industry
Medtech Dive
Thu, 03/10/22 - 10:32 am
FDA
regulatory
devices
MDUFA
Medtech
Omnibus spending bill would give FDA a $102M boost for FY2022
RAPS.org
Wed, 03/9/22 - 11:11 pm
regulatory
legislation
FDA
FDA's oncology adcomm to review PI3K inhibitors in blood cancers in April
Endpoints
Wed, 03/9/22 - 10:59 am
FDA
regulatory
blood cancers
PI3k inhibitor
FDA offers funding for biosimilar regulatory science pilot
RAPS.org
Mon, 03/7/22 - 10:54 pm
regulatory
FDA
biosimilars
FDA’s OPQ 2021 report focuses on pandemic responses
RAPS.org
Wed, 02/23/22 - 10:02 pm
FDA
regulatory
pandemic
OPQ
regulatory inspections
FDA’s Califf shares priority list with agency staff
RAPS.org
Sun, 02/20/22 - 11:50 am
FDA
regulatory
Robert Califf
pandemic
COVID-19
misinformation
This Week at FDA: QSR meeting, Woodcock’s new role, and more
RAPS.org
Fri, 02/18/22 - 10:29 am
FDA
regulatory
QSR
devices
Janet Woodcock
Robert Califf
FDA says volume manufacturing deadline is not a requirement after drugmakers lash out
Endpoints
Thu, 02/17/22 - 10:51 am
FDA
drug manufacturing
regulatory
CARES Act
After a contentious lead-up, Rob Califf likely to be confirmed as FDA commissioner next week
Endpoints
Thu, 02/10/22 - 08:05 pm
FDA
regulatory
Robert Califf
Joe Biden
Senate
As FDA resumes foreign inspections, GAO recommends revamping the program
RAPS.org
Tue, 02/8/22 - 11:52 pm
GAO
FDA
regulatory
foreign inspections
ADCs in the pipeline: FDA spells out clinical pharmacology musts for sponsors
Endpoints
Mon, 02/7/22 - 11:21 pm
FDA
regulatory
antibody-drug conjugate
Clinical Pharmacology
Must-pass user fee deals: Biopharma companies fund more than 80% of FDA's review staff, CDER head tells Congress
Endpoints
Thu, 02/3/22 - 11:39 pm
FDA
user fees
regulatory
Califf pledges not to use ‘revolving door’ between FDA and industry
Pharmaforum
Thu, 02/3/22 - 10:33 am
Robert Califf
FDA
regulatory
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