Article
20 Oct 2025
What To Watch: Human Cell And Tissue Product Regulation
RANKINGS
This author falls within the Top 20% for their listed topics and industry categories. Based on Mondaq users readership, this author is ranked as VERY POPULAR in United States
AUTHORS CONTENT
Article
08 Oct 2025
FDA Touts Continued Commitment To Cell And Gene Therapy Products Through Trio Of Guidances
Article
03 Oct 2025
FDA's Wave Of Untitled Letters Signals Stricter Scrutiny For DTC Pharma Ads
Article
23 Sep 2025
FDA Unleashes Wave Of Enforcement: The Industry Faces A Crackdown On Drug Advertising
Article
12 Sep 2025
FDA's Vast Ad/Promo Warning – Enforcement Ramp-Up Or PR Nothingburger?
Article
07 Aug 2025
What To Watch: WHOOP Warning Letter
Article
01 Aug 2025
DOJ False Claims "Working Group" Update
Article
03 Jul 2025
What's Going On With Human Cell And Tissue Products?
Article
23 Jun 2025
What To Watch: Potential Increase In Enforcement Of "RUO" Diagnostics
Article
16 Jun 2025
FDA Ratchets Enforcement On Social Media Promotion In New Warning Letter
Article
20 May 2025
Reflections On The FDLI 2025 Annual Conference – Differing Tones, Shared Goals
Article
14 May 2025
Onshoring Pharma Ops: Reading Recent EO And Policy Tea Leaves
Article
10 Apr 2025
LDT Final Rule Series: Part 4 – Rule Overturned By Federal District Court
Article
10 Apr 2025
LDT Final Rule Series: Part 4 – Rule Overturned By Federal District Court
Article
13 Mar 2025
Reminder: FDA Does, In Fact, Review DOF
Article
12 Feb 2025
Finally, FDA's Final Word On Unapproved Use Communications
Article
03 Feb 2025
FDA Dumps Trio Of Device-Related Guidances Prior To Administration Change
Article
17 Jan 2025
FDA Furthers Efforts To Improve The Accelerated Approval Pathway Through New Draft Guidance On Confirmatory Trials
Article
27 Dec 2024
New Accelerated Approval Guidance Underscores Need For Accountability
Article
19 Dec 2024
LDT Final Rule Series: Part 3 – Legal Challenges