Winston S. Kirton

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FDA Announces Impact of Ending COVID-19 Public Health Emergency

Photo of Winston S. KirtonPhoto of Lee H. RosebushPhoto of Laura MacherelliPhoto of Marc WagnerBy Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli and Marc Wagner on Posted in Alert
On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11. Of the 72 COVID-19-related guidance … Continue Reading

FDA Issues Guidance on Clinical Research with Cannabis

Photo of Lee H. RosebushPhoto of Randal M. ShaheenPhoto of Winston S. KirtonPhoto of Laura MacherelliBy Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton and Laura Macherelli on Posted in Alert
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The need for the guidance stemmed from the 2018 Farm Bill, which legalized the production and sale of hemp (cannabis below 0.3 percent delta-9 THC by … Continue Reading

Note of Caution to Compounding Pharmacies

Photo of Lee H. RosebushPhoto of Winston S. KirtonPhoto of Laura MacherelliPhoto of Marc WagnerBy Lee H. Rosebush, Winston S. Kirton, Laura Macherelli and Marc Wagner on Posted in Alert
Former co-owner of the now defunct New England Compounding Center (NECC) Gregory Conigliaro may face prison time for conspiring to defraud the U.S. Food and Drug Administration (FDA). Prosecutors argued Conigliaro conspired with more than a dozen others at NECC to deceive and defraud the FDA by misrepresenting the facility as solely a compounding pharmacy … Continue Reading
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