Regulatory

  1. Securing FDA Expanded Access Designation For An Emergent Public Need 6/26/2023

    In this Q&A, SIGA Technologies Executive Vice President and Chief Scientific Officer Dennis Hruby discusses the journey toward expanded access, or compassionate use, of TPOXX and the importance of keeping a pulse on — and reacting to — an emerging public need.

  2. Navigating Regulatory Guidelines For Effective Tech Transfer 6/22/2023

    The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.

  3. The Future Looks Promising For CAR T-Cell Therapy 6/20/2023

    This article shares new market research for CAR T-cell therapies. The U.S. leads the market, but there is positive movement in Europe and other areas of the world.

  4. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

  5. What Sponsor Companies Need To Know About The Updated DOJ Corporate Compliance Programs 6/13/2023

    In March 2023, the criminal division of the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs document to serve as a guide for prosecutors in assessing the effectiveness of a company's compliance program.

  6. New DSCSA Compliance Blueprint Includes FDA & Industry Input 6/1/2023

    As we approach the final phase of a 10-year rollout of the Drug Supply Chain Security Act (DSCSA), which aims to create a more secure, interoperable drug supply chain in the U.S., pharma manufacturers, distributors, and pharmacies must all ensure they are ready for its full implementation starting on Nov. 27, 2023.

  7. FDA Releases Draft Guidance On Decentralized Clinical Trials 5/18/2023

    The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.

  8. Considerations For Compliance With CTIS Submissions Under The EU-CTR 5/1/2023

    This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.

  9. 8 Key Takeaways For FDA Inspections In The FDORA 5/1/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023 (Public Law 117-328), became law on Dec. 29, 2022.  FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and unannounced foreign inspections.

  10. New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics 4/21/2023

    On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.