Article
19 Nov 2025
New FDA Guidance Aims To Simplify The Biosimilar Approval Process
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
03 Oct 2025
Life Sciences And Medtech Policy Update: Key Things To Know Q4 2025
Article
07 Aug 2025
Move Fast: FDA Is Accepting Submissions For The Pilot Program Class For FDA Commissioner's National Priority Voucher Program
Article
16 Jul 2025
FDA's Push For "Radical Transparency": Key Takeaways From The Agency's Publication Of Complete Response Letters
Article
19 May 2025
President Trump Issues Two Executive Orders Concerning The Affordability And Accessibility Of Drugs
Article
14 May 2025
Most Favored Nation Drug Pricing Executive Order Resurrects Prior President Trump Policy
Article
28 Apr 2025
Charting A Conditional Approval Pathway For Rare Disease Drugs – A Top Priority For A Revamped FDA?
Article
22 Jan 2025
How To (Finally) Get Your SIUU Out: FDA Issues Final Guidance On Communicating Off-Label Scientific Information
Article
03 Oct 2024
A Look Ahead In Life Sciences: What We Are Tracking In The Fourth Quarter Of 2024 And Beyond
Article
01 Jul 2024
FDA Issues Overdue Draft Guidance On Clinical Trial Diversity Action Plans
Article
16 Jan 2024
Goodwin Releases Update To Its Comprehensive Guide To Biosimilars Litigation And Regulation In The U.S.
Article
09 Jan 2024
A Look Ahead In Life Sciences: What We Are Tracking In Q1 2024 And Beyond
Article
27 Oct 2023
How To Get Your SIUU Out: FDA Provides Long-Awaited Update For Industry On Communicating Off-Label Information
Article
28 Mar 2023
Clinical Trial Diversity Plans And Rare Diseases
Article
02 Jan 2023
Congress Expands Pathway For Drug & Device Manufacturers' Pre-Approval Communication Of Health Care Economic Information To Payors, Formularies, & Similar Entities
Article
02 May 2022
Clinical Trial Diversity Planning For Sponsors: What To Know About FDA's Recent Draft Guidance