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Apr 15, 2009 (Vol. 29, No. 8)

Spotlight on the FDA

Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues

  • Editor's Note

    This month GEN introduces an extremely important and pertinent regular column for our subscribers. "Spotlight on the FDA" will provide our readers with a concise analysis of FDA initiatives and activities and how they will directly impact your R&D and biomanufacturing operations on a global scale.

    Bruce F. Mackler, Ph.D., J.D., a senior advisor in FDA matters and FDA due diligence issues for financial/investment groups and companies, will serve as the main columnist. He has over 27 years of hands-on regulatory and legal experience working with the FDA on traditional and biotech-derived products.

  • Author’s Bio

    Bruce F. Mackler’s, Ph.D., J.D. (bmackler@brucemackler.net), has 28 years of FDA legal and regulatory experience in biomedical products. As an FDA adviser, he assists financial groups like venture funds that are performing due diligence on biomedical opportunities prior to making an initial investment. He consults on integrated FDA, technical, and business issues by assessing portfolio companies and conducts approval risk analyses for analysts and investors.

    His business acumen stems from working in sales/manufacturing in a family business, owning several bioservice businesses, holding management roles like interim COO and regulatory affairs vp in various start-up companies, and being a university/NIH researcher for 15 years.

    Dr. Mackler has a Ph.D. from the University of Oregon Medical School (1970) in the area of immunology/microbiology and has authored more than 100 published scientific papers and abstracts. He has written/edited the Life Science Due Diligence and Regulatory Newsletter and the TVM-Capital Regulatory Bulletin.

    He also advises early- and late-stage biomedical companies, serves on several boards of directors and scientific advisory boards of biomedical companies, and is an active investor. His areas of expertise include FDA regulatory approval strategies, pre-INDs/IDEs, 510ks, PMAs/ NDAs/BLAs, manufacturing/QA/QC, and how to effectively interact with FDA. 

    Dr. Mackler co-founded the Association of Biotechnology Companies (ABC) with six small biotech firms and helped it grow to over 250 members. ABC later merged to form the Biotechnology Industry Organization (BIO).


Readers' Comments

Posted 05/04/2009 by QA Manager

As a Quality professional in biotech working with a contractor who appears to be overly concerned with their liability, I think the FDA needs to seriously spell out their expectations in a written guidance. Has this been done? I personally do not understand as an IND or NDA holder, where a contractor can be held responsible for how I intend to or ultimatley do use the products I ask them to make for me.

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