Regulatory Blog

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

  • 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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  • CBER Launches CATT to Facilitate Innovation

    CBER Launches CATT to Facilitate Innovation

    CBER Advanced Technologies Team (CATT) is a new program designed to address regulatory challenges associated with development of advanced technologies for manufacturing and testing of CBER...

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  • RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data

    RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data

    In my previous articles I talked about the history of RIM, structural must-haves, and provided a quick list of these features for a RIM system.   If you missed them, you can find all the...

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  • Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    The FDA recently released a draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development.”  This is a very informative document, since a main reason why FDA drafted it is to...

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  • New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines

    New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines

    Medsafe opened a public consultation on 27th June, they are proposing that manufacturers of medicines and related products include substances that may cause an allergic reaction on their...

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  • All EU Members Have Now Joined!

    All EU Members Have Now Joined!

    The pharmaceutical facility current Good Manufacturing Practice (cGMP) inspections are the key to ensure the quality of drugs/medicines for the patients around of the world.  While it is critical...

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  • RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform

    RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform

    In my previous articles (Part 1, Part 2) we talked about the history of RIM and structural must-haves for a RIM system. It’s also important to know the questions that will be asked of the data as...

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  • Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...

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  • English Requirement for FDA GMP Documents

    English Requirement for FDA GMP Documents

    Generally, overseas manufacturers in non-English speaking countries have their GMP documentation in the local language so that the staff working at the facility are able to read and understand the...

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