REGULATORY ARTICLES

  • FDA FY2018 Human Tissue And Cell Therapy Observations And Trends
    FDA FY2018 Human Tissue And Cell Therapy Observations And Trends

    A comprehensive GMP intelligence program includes monitoring of health authority enforcement actions, including FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, and EU reports of GMDP noncompliance. This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.

  • Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness
    Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness

    Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.

  • FDA Updates Several 510(k) Guidance Documents
    FDA Updates Several 510(k) Guidance Documents

    The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  • How Pharma Manufacturers Must Prepare For EU MDR And IVDR
    How Pharma Manufacturers Must Prepare For EU MDR And IVDR

    Pharmaceutical companies producing combination products or companion diagnostics may not have a clear idea of how the EU MDR and EU IVDR will effect their products. No medical device will escape regulatory scrutiny, regardless of whether its function is central or ancillary to the drug product.

  • FDA FY2018 Drug Inspection Observations And Trends
    FDA FY2018 Drug Inspection Observations And Trends

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  • FDA’s New Population Pharmacokinetics Guidance: What You Need To Know
    FDA’s New Population Pharmacokinetics Guidance: What You Need To Know

    The FDA’s Population Pharmacokinetics Guidance for Industry draft calls for sponsors of new drug and biologics license applications to apply population PK analysis. This column covers the implications for drug and device manufacturers.

  • Analysis: FDA’s Draft Guidance On Premarket Combination Products Review
    Analysis: FDA’s Draft Guidance On Premarket Combination Products Review

    The new EU draft guidance Guideline on the quality requirements for drug-device combinations and U.S. draft guidance Principles of Premarket Pathways for Combination Products are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail, starting with the U.S. guidance.

  • FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance
    FDA Rapid Inquiry Program Takes Aim At Regenerative Medicine Compliance

    Regenerative medicine holds promise, though evidence to back claims about current therapies is underwhelming. The FDA's announcement of the Tissue Reference Group Rapid Inquiry Program returns our attention to the administration's regenerative medicine policy framework.

  • FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
    FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  • Examining FDA’s New Patient Labeling Draft Guidance
    Examining FDA’s New Patient Labeling Draft Guidance

    The FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

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