Archives: Alert

FDA Announces Impact of Ending COVID-19 Public Health Emergency

By Winston S. Kirton, Lee H. Rosebush, Francis Palumbo, Laura Macherelli and Marc Wagner on March 16, 2023 Posted in Alert

Front Line Worker Holding Syringe and Vial Filled with Coronavirus Vaccine or Medicine Silhouetted Against American Flag

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

By Lee H. Rosebush, Randal M. Shaheen, Winston S. Kirton and Laura Macherelli on January 27, 2023 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

FDA Approves Abortion Pill for Sale by Retail Pharmacies

By Amy Fouts and Claire Bass on January 13, 2023 Posted in Alert

Pharmacist and customer discussing prescription in pharmacy

On Jan. 3, the Food and Drug Administration (FDA) finalized a rule allowing more retail pharmacies to dispense abortion pills upon completion of a certification process. The FDA finalized the changes after reviewing supplemental applications from manufacturers of the drug mifepristone requesting modification of the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. Read full … Continue Reading

Note of Caution to Compounding Pharmacies

By Lee H. Rosebush, Winston S. Kirton, Laura Macherelli and Marc Wagner on December 20, 2022 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

Georgia 6-Week Abortion Law Is Void Ab Initio

By Amy Fouts and Claire Bass on November 18, 2022 Posted in Alert

On Nov. 15, the Superior Court of Fulton County issued an order finding that two sections of the Georgia LIFE Act (the Act) – Sections 4 and 11 – were void ab initio. Section 4 of the Act criminalized abortions after the detection of a heartbeat (typically around six weeks into the pregnancy), with exceptions … Continue Reading