Regulatory

  1. Insights Into The FDA's Guidance On Managing Drug Supply 7/3/2023

    This new guidance describes the scope to include both permanent discontinuances as well as temporary interruptions in the manufacture of drugs including biological products and blood and blood-derived products.

  2. FDA's Digital Health Technologies Framework Addresses Important Challenges 7/3/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  3. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities 6/29/2023

    These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.