Stephen Goldner

Department of Pharmaceuticals Research, Pure Green Pharmaceuticals, West Bloomfield, 48323, USA

Biography

Steve Goldner, Esq, RAC is Chief Executive Officer, Board Chairman and founder of Pure Green Pharmaceuticals, Inc. and the predecessor company, Pure Green LLC. Mr. Goldner previously served as Vice President Regulatory Affairs at Ferndale Pharma, Inc.; Vice President, Regulatory Affairs at ICN Pharmaceuticals, Inc.; and Manager of Corporate Regulatory Affairs for FDA at Unilever. A serial entrepreneur and FDA regulatory affairs expert, Mr. Goldner founded Regulatory Affairs Associates, an FDA regulatory advisory firm, where he and his team obtained United States FDA approval for over 240 medical devices and drugs, with successful corresponding approvals in 40 other countries.

Publications
  • Case Report   
    Low Dose Cannabidiol for the Treatment of Mild to Moderate Musculoskeletal Pain
    Author(s): Matthew K Caloura*, Debra Kimless, Susan Lewis and Stephen Goldner

    Sixteen healthy, cannabis and cannabidiol (CBD) naïve patients with mild to moderate musculoskeletal pain took a single dose of 5 mg CBD sublingual tablet. Patients were using other-the-counter (OTC) medications to treat various manifestations of musculoskeletal pain, including neck, back, muscle aches, and arthritis. The average self-reported pain scale score (NPRS), measured on a scale of 0-10, was 5.13 prior to taking the CBD tablet. After tablet administration, the patients self-reported their pain scale score over a 2-hour period. All patients reported pain reduction within 20 minutes after taking the tablet and continued over the 2-hour period where the average reported pain was reduced by 20-fold (NPRS 5.13 to 0.25) and was statistically significant (p<0.001). No patients reported any adverse effects and characterized the experience as positive. Th.. View more»

    DOI: 10.35248/2684-1320.21.7.156

    Abstract HTML PDF