Regulatory

31. 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.

32. 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.

33. 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that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.

34. 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.

35. 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.

36. 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.

37. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift 4/3/2023

    There is a regulatory paradigm shift underway to protect digital assets and data. But, few laboratories, CROs and CDMOs, and pharmaceutical and medical device manufacturers can meet the NIS2 cybersecurity requirements today.

38. How Biopharmas Can Navigate Data Privacy Laws And Unlock Value 4/3/2023

    It should be no surprise that data privacy and responsibility is emerging as a high-priority target for life sciences companies, driven by regulatory compliance and market differentiation.

39. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

    Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.

40. Draft FDA Labeling Guidance Proposes More Clarity For Providers 3/7/2023

    The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.