Regulatory

61. 2 Years After Germany's Regulation For Digital Health Apps, What Can We Learn? 6/10/2022

    At the end of 2019, the Digital Healthcare Act introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany. Many consider the act a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Two years and 28 approved digital health apps later, what can we learn?

62. FDA Finds Drug Shortages Are Mostly Caused By Quality Issues 6/6/2022

    New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

63. The Voluntary Improvement Program: FDA Seeks Public Comment On Draft Guidance 6/6/2022

    The FDA seeks comments on its proposed guidance describing its policy regarding FDA's participation in the Voluntary Improvement Program. The program is facilitated by the Medical Device Innovation Consortium. Comments are due by July 5, 2022.

64. FDA Releases Guidance On Cybersecurity In Medical Devices 5/31/2022

    The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).

65. Therapeutic Oligonucleotides: Regulations & Quality Standards 5/20/2022

    Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

66. Patents Or Trade Secrets? How To Choose The Best IP Safeguard For R&D Assets 5/2/2022

    There is no one-size-fits-all answer to the question of whether to pursue a patent or trade secret, but there are guidelines available for IP practitioners in these specialized fields where R&D is a key company asset and of paramount importance to protect.

67. 4 Pitfalls To Avoid With RWE For Regulatory Submissions 4/19/2022

    Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

68. 5 Key Steps For FDA Q-Submissions 4/18/2022

    Most medical device designers and developers have some familiarity with the FDA's Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.

69. FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs 4/14/2022

    The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.

70. Biopharma Patents: Satisfying Descriptions For Claimed Ranges 4/11/2022

    In pharma patents, ranges are often recited in patent claims to broaden the scope of the claim coverage. Claims may also include a temperature range or pH range used in making a drug. This article shares the key takeaway for industry from a recently decided court case.