Regulatory

1. AI Is A Tool — Not A Replacement — For Human Innovation In Drug Discovery 9/4/2024

   This attorney provides practical advice. Can artificial intelligence (AI) make drug discovery easier? Yes! Will we lose the human component essential to the innovation culture? No.

2. When Consumer Protection, Unfair Trade Practices, And AI Collide 7/18/2024

   The EU, and a growing number of U.S. state governments, are extending consumer protection laws to AI technologies. Life sciences companies should monitor new policy developments and understand how and where specific uses of AI will be regulated.

3. USPTO Proposed 'Terminal Disclaimer' Rule Could Impact Life Science Patent Protections 7/15/2024

   A proposed rule change by the USPTO to tie patent validity together based on the filing of terminal disclaimers would have a significant impact on how life sciences patents are prosecuted. 

4. Trendspotting: COVID-19 Related Investor Lawsuit Court Decisions 6/21/2024

   Court rulings on COVID-19 related investor lawsuits over the last three years have been mixed, but manufacturing issues related to vaccine production have proven to be the strongest claims against product developers.

5. FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria 5/28/2024

   Understand the latest FDA guidance on cancer clinical trials with summary and content from Marjorie Zettler, Ph.D., MPH.

6. Understanding And Navigating Diverse Regulatory Environments 2/21/2024

   Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.

7. A New Year's Resolution Suggestion For The FDA 1/22/2024

   Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

8. Trends In Next-Generation Delivery Technologies 11/22/2023

   Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

9. Understanding The FDA's Current Focus On REMS 11/1/2023

   Our Life Science Connect sister publication, Bioprocess Online, asked Linda Pissott Reig, an attorney at Buchanan Ingersoll and Rooney, to explain more about why the FDA is focusing on safety programs for drugs with high-risk profiles and what it means for drug companies that have REMS products in their portfolios.

10. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 11/1/2023

    The FDA employs various special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and biologics license applications (BLAs), others may abbreviate the duration of clinical trials.