Pharmaceutical & Health Technology

Hi, 

What would you wise folks recommend as the best source(s) to get very current info on FDA regulatory affairs, particularly regarding medical devices and drugs? FDA itself? Or, is there another source (inlcuding licensed/subscription sources) that you would recommend? 

Many thanks,

Michael

------------------------------
Michael Sholinbeck
he/him/his
Fellow of SLA
DICE Community Co-Leader
https://connect.sla.org/diversity
Public Health Librarian/Optometry Liaison
University of California Berkeley
msholinb@library.berkeley.edu
------------------------------

Hi Michael,

Full disclosure that I work for STAT, but I just wanted to share a few ways that we uniquely cover this space.

• On the devices front, we're continuing to significantly expand our coverage of medical devices, including regulation, reimbursement, as well as accountability reporting on patient harms and scientific shortcomings. Here are a few recent story examples:
  • https://www.statnews.com/2023/01/10/medical-devices-fda-510k-recall/
  • https://www.statnews.com/2023/02/02/blood-clot-vena-cava-filter-device-embolism/
  • https://www.statnews.com/2022/12/14/right-to-repair-medical-devices-health/
• Regarding drugs, we remain the destination for coverage of the accelerated approval pathway and Washington's attempts to change both the process and the way those drugs are covered. Here's a scoop about the way advisers are talking about Coverage with Evidence Development, the way Medicare covers drugs like Aduhelm and Lequembi.
• Our team in Washington keeps a close eye on key FDA personnel changes and potential congressional reforms, and we're gearing up to cover the new House Republican majority's oversight of the agency, too.
• For a 3000 foot view, you can explore many relevant articles right at these topic landing pages here https://www.statnews.com/topic/fda/ and here https://www.statnews.com/topic/government-agencies/.
• STAT+ subscribers also have access to the Breakthrough Device Tracker, an authoritative database of FDA's fast-tracked medical devices: https://www.statnews.com/feature/stat-plus/breakthrough-device-designation-fda-tracker/ (I've attached a screenshot below here since I know you may not be able to view it)
• We've even authored a primer report on the FDA's drug approval pathways - https://reports.statnews.com/products/speed-and-safety-fdas-drug-approval

If any of that seems relevant to your or your community's needs, I'm more than happy to give you quick demo/free trial etc. or feel free to just ping me with any additional specific questions. 

My best,

Amanda

amanda.garces@statnews.com 

------------------------------
Amanda Garces
STAT
amanda.garces@statnews.com
6179297631
------------------------------

Original Message:
Sent: 02-21-2023 13:26
From: Michael Sholinbeck
Subject: best source for FDA regulatory news (devices & drugs)

Hi, 

What would you wise folks recommend as the best source(s) to get very current info on FDA regulatory affairs, particularly regarding medical devices and drugs? FDA itself? Or, is there another source (inlcuding licensed/subscription sources) that you would recommend? 

Many thanks,

Michael

------------------------------
Michael Sholinbeck
he/him/his
Fellow of SLA
DICE Community Co-Leader
https://connect.sla.org/diversity
Public Health Librarian/Optometry Liaison
University of California Berkeley
msholinb@library.berkeley.edu
------------------------------