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About Malcolm

Washington DC, USA

+14 year(s) experience

Malcom Spicer
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets for more than a decade and currently is Senior Editor at Informa Pharma Intelligence’s HBW Insights. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drug, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.
Previously, Malcolm covered these industries for the Tan Sheet (now part of HBW Insight), joining the Tan Sheet as Managing Editor in August 2006. He has continued to lead coverage of consumer health products as the consumer sector content has evolved at Informa and he collaborates on coverage strategy with editors at Pink Sheet and other publications. Malcolm also has had experience in covering US health care policy and the global telecommunications industry as well as reporting on topics from litigation to lifestyles, and from crime to commerce for daily newspapers.


Analyst Articles

Articles by Malcolm

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

    OTC_Drug_Oversight_By_US

    CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    Complicated Regulatory Odyssey Steers FDA Toward Rule On CBD In Supplements

    Before Congress de-scheduled hemp at end of 2018 and forced agency's hand on considering lawful use of ingredients derived from the plant in supplements and food, the floodgate for sales of the products was opened in 2013 by a DoJ policy change to de-emphasize enforcement of most federal marijuana laws.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    Long-term E-cigarette Use Could Spark More Smoking, French Study Suggests

    Long-term E-cigarette Use Could Spark More Smoking, French Study Suggests

    Research in JAMA Internal Medicine studied "longitudinal associations between [e-cigarette] use and tobacco smoking patterns in a large population-based cohort study" and found use was associated with reduction in smoking and an increased probability of smoking cessation. But the researchers saw that e-cigarette users who quit tobacco "tended to relapse to smoking more frequently than" former smokers who didn't use e-cigarettes.

    Topic medtech

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    FDA Consumer Health Market Oversight Stays In Spotlight In Gottlieb's Final Week

    FDA Consumer Health Market Oversight Stays In Spotlight In Gottlieb's Final Week

    In four days before Scott Gottlieb's stint as commissioner ended, FDA announced official start of initiative to consider regulatory pathways to make CBD compliant as a dietary ingredient, launched another shot across kratom sector's bow and noted more examples of e-cigarette marketers crossing regulatory lines.

    Topic fda