Regulatory

  1. 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.

  2. 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.

  3. 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.

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 FDA Releases Draft Guidance On Decentralized Clinical Trials 5/18/2023

    The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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.

  5. 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.

  6. 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.

  7. 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.

  8. Recent FDA Inspections In India Indicate New Focus On Tablet Press Operations 4/21/2023

    Over the past few years, the FDA investigators in India have shifted their focus away from laboratory and data manipulation and toward a closer look at tablet press operations. The new interest centers on critical process parameters, the automatic weight control system, and more.

  9. Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug Product 4/7/2023

    With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.

  10. Avoid Launch Delays By Planning For An FDA-Required REMS 4/3/2023

    If you don't account for the time and effort necessary to develop, implement, and operate a REMS, you could be significantly impacting launch timing and patient access.