Regulatory

51. 5 Specifications That The FDA's Diversity Plan Needs To Include 11/1/2022

    The FDA’s recommendations provide a much-needed action plan to jumpstart the changes that need to be made to ensure inclusive care, yet these recommended guidelines only scratch the surface of ideal action in clinical trials.

52. FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics 10/20/2022

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

53. Tips For Your Virtual Meetings With The FDA 10/7/2022

    It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

54. FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

55. FDA's RTOR Program: Draft Guidance & Insights 10/4/2022

    First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.

56. Data: The Future Of Regulatory Info Management In Europe 10/3/2022

    The answer to many of our COVID-related real-world challenges lies in greater data centricity supported by the adoption of new technologies, and life sciences companies must play their own part in driving change.

57. How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws 9/26/2022

    Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.

58. Tips For Filing Regenerative Medicine Patents 8/26/2022

    The patent eligibility requirement of U.S. patent law creates obstacles for the regenerative medicine sector. This article examines common regenerative medicine claims for cell and gene therapies as well as biologics that are likely patent ineligible and provides potential claim amendments and other strategies to be successful.

59. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.

60. Heightened Standards For Satisfying Written Description In Pharma Patents 7/27/2022

    In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.