Article
21 Nov 2025
FDA's Move To Streamline Biosimilar Approval: What In-House Counsel Must Prepare For Now
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
17 Oct 2025
Conception & Inventorship Under Pharmaceutical Patent Law: Lessons And Best Practices
Article
01 Aug 2025
Preserving Attorney-Client Privilege In Mergers And Acquisitions: Navigating The Common Interest Doctrine
Article
04 Jul 2025
The Perils Of Broad Patent Claims: From Issuance To Invalidity
Article
27 Jun 2025
Your Rights If FDA Agreed To Your Proposed Q1/Q2 ANDA Formulation But Sends A Refuse To Receive (RTR) Instead?
Article
19 Mar 2025
Patent & Regulatory Legal Issues Related To Fertilizers, Fungicides, Pesticides, & Bulk Chemicals
Article
17 Mar 2025
Intellectual Property Issues Related To Artificial Intelligence: A Deeper Dive Into Patent, Copyright, & Trade Secrets Challenges
Article
10 Jan 2025
Pending 2025 FDA Legislation On Pharmaceutical Development & Marketing: A Comprehensive Industry Impact Analysis
Article
19 Nov 2024
Infringing Your Own Intellectual Property: Understanding The Paradox
Article
17 Oct 2024
Proving Patent Infringement – Double Counting Pharmaceutical Ingredients When One Element Satisfies Two Claim Limitations
Article
28 Aug 2024
The Right To Repair Versus Reconstruction Under U.S. Patent Law: An In-Depth Analysis
Article
25 Jul 2024
Does Drug Quality Matter? Do Lives Matter?
Article
24 Jul 2024
Data Falsification/Data Integrity - You Can Run But You Cannot Hide
Article
24 Jul 2024
Inducement To Infringe Is Not A Strict Liability Test
Article
24 Jul 2024
The Culture Of CGMP Compliance - More Falsified Data
Article
17 Jun 2024
Navigating Administrative Law: Understanding The Basics Of Challenging Federal Agency Decisions
Article
16 May 2024
Understanding Product-By-Process Claims In Patent Law
Article
16 May 2024
The Role Of Prior Art In Patent Law – Old And Admitted Prior Art
Article
16 May 2024
Five (5) & Ten (10) Year Data Exclusivity For New Drugs – When To File Generic Drug Applications
Article
16 May 2024
Billion Dollar Verdicts Wiped Out Due To Patent Law's Written Description