Regulatory Blog

The latest information on Regulatory topics impacting Biopharmaceutical and Medical Device companies.

  • A Long and Winding Road for Transdermal Products – FDA Has It Covered

    A Long and Winding Road for Transdermal Products – FDA Has It Covered

    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...

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  • Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...

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  • Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...

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  • Biosimilars in China

    Biosimilars in China

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

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  • Rescuing Product Approvals from Data Integrity Issues

    Rescuing Product Approvals from Data Integrity Issues

    The pharmaceutical industry is inundated with a plethora of communications about data integrity.  Most of those are focused on the downside – operational snags, negative inspection findings,...

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  • Commercializing Gene and Cellular Therapy

    Commercializing Gene and Cellular Therapy

    Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities.  Designing a facility or finding a contract manufacturer to meet the...

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  • Impact of MDR, Article 117 medicinal products with an integral medical device

    Impact of MDR, Article 117 medicinal products with an integral medical device

    The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three current Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations...

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  • Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...

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  • New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...

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  • Tips from FDA – Put Design of Experiments to Use in Drug Applications

    Tips from FDA – Put Design of Experiments to Use in Drug Applications

    One of the benefits to having worked at FDA was the opportunity to gain exposure to how a wide variety of manufacturers perform product development and manufacturing and how they present...

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  • Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products

    Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products

    Conducting clinical trials for innovative gene therapy products that include viral vector-based products and gene-modified cells is not entirely straightforward.  Operationally, there are...

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  • What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    Drug Master Files (DMFs) may be submitted to the FDA to provide confidential and often proprietary information regarding facilities, processes, or components used in the manufacturing,...

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  • Further Limits on The Use of Guidance for Enforcement – How Will FDA React?

    Further Limits on The Use of Guidance for Enforcement – How Will FDA React?

    On October 9, 2019, the President signed two executive orders that address how the federal government develops guidance and limits the use of guidance in civil administrative enforcement...

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  • Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?

    Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?

    Certain areas of the global biopharmaceutical market continue to struggle with poor product quality, which has impacted the U.S. market and its patients.  This is a result of a perfect storm...

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  • What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products

    What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products

    The presence of microorganisms in sterile drug products is of paramount concern to patient safety.  However, it may be less obvious why concern for the presence of microorganisms in...

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  • Advice for Handling Potentially Mutagenic Impurities in Regulatory Submissions

    Advice for Handling Potentially Mutagenic Impurities in Regulatory Submissions

    The presence of various nitrosamine-related impurities in the angiotensin II receptor blocker (ARB) class of drugs and now ranitidine has been the subject of numerous pieces in the popular...

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  • PAI Objectives Remain the Same, However Important Updates are Included

    PAI Objectives Remain the Same, However Important Updates are Included

    Having been involved with the Concept of Operations for Integration of FDA Facility Evaluation and Inspection Program for Human Drugs  while at FDA, I am encouraged to see the release of a...

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  • When There Is No Guidance – Navigating Regulatory Meetings With FDA

    When There Is No Guidance – Navigating Regulatory Meetings With FDA

    For manufacturers who request meetings with FDA while developing a drug, biologic or medical device, there is a plethora of guidance available based on the user fee programs enabling...

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  • FDA Needs To Know How 503B Compounders Work

    FDA Needs To Know How 503B Compounders Work

    FDA recently published a notice in the Federal Register regarding proposals to collect information during proposed research initiatives to understand challenges and opportunities encountered by...

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  • FDA & EMA Joint Report on Early Access Pathways

    FDA & EMA Joint Report on Early Access Pathways

    FDA recently published in coordination with the European Medicines Agency (EMA) a report from a joint FDA-EMA workshop with stakeholders on supporting product quality development in early access...

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