Regulatory Blog

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

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  • Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    The FDA recently released a draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development.”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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  • Bispecific Antibody Development Program Guidance

    Bispecific Antibody Development Program Guidance

    Earlier this month FDA released a draft guidance called “Bispecific Antibody Development Programs”.  This is a welcome addition to FDA’s set of guidance documents for biotechnology...

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  • The State of Germline Gene Editing. What We Don’t Know!

    The State of Germline Gene Editing. What We Don’t Know!

    According to NIH “germline alteration involves a specific attempt to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed...

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  • Key Questions to Consider When Licensing Cell & Gene Therapy Products

    Key Questions to Consider When Licensing Cell & Gene Therapy Products

    Manufacturers often ask if there is a checklist for CMC readiness before entering pivotal or Phase III study or if they plan to ask the agency for one of many expediated designations. Since the...

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  • Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products

    Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products

    For a Specific Group or Class of Oncology Products

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  • Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?

    Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?

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  • How New India Clinical Trial Regulations Will Improve Drug Development

    How New India Clinical Trial Regulations Will Improve Drug Development

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  • Good Tissue Practices (GTP):  A Lesser-Known GxP

    Good Tissue Practices (GTP): A Lesser-Known GxP

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  • FDA Releases a Biopharmaceutical Naming Update

    FDA Releases a Biopharmaceutical Naming Update

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  • Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules

    Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules

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  • FDA Publishes Guidances Aimed at More Inclusive Eligibility Criteria for Cancer Clinical Trials

    FDA Publishes Guidances Aimed at More Inclusive Eligibility Criteria for Cancer Clinical Trials

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