Regulatory Articles

  1. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

  2. Transitioning From Research To Drug Formulation And Development 11/27/2023

    The transition from academic research and studies to industry research demands that individuals master additional skills, set different objectives, and define “success” differently.

  3. A Brief Guide For Vaccine Companies Working Toward FDA Approval For the First Time 11/22/2023

    This article outlines best practices for expediting the FDA approval process while maintaining safety and efficacy standards. Tips are related to vaccine R&D, understanding the Emergency Use Authorization (EUA), post-approval surveillance and monitoring, and more.

  4. Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies 11/10/2023

    On Sept. 20, 2023, in Baxalta v. Genentech, the Federal Circuit invalidated patent claims directed to functionally claimed antibodies, finding that they failed to satisfy the enablement requirement. The author of this article is a patent attorney and he shares the key takeaways for biotech/pharma companies going forward.

  5. Legal And IP Protection For New Biotechs 10/31/2023

    Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs. 

  6. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

  7. FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology 10/3/2023

    The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug–drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.

  8. Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture 9/13/2023

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

  9. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 9/8/2023

    The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?

  10. Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi 8/24/2023

    In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.