Tag Archives: FDA

Supreme Court Orders That Mifepristone Remain Widely Available Pending Appeal in Fifth Circuit

By Amy Fouts and Scott P. Robertson on April 25, 2023 Posted in Post-Dodds

On Friday, April 7, the Northern District of Texas issued a decision blocking the prescribing and dispensing of mifepristone nationwide. The court held that plaintiffs had a substantial likelihood of success on the merits regarding their arguments that the FDA approval of the drug in 2000 was arbitrary and capricious. Accordingly, the court stayed the … Continue Reading

Cybersecurity in Medical Devices

By Lee H. Rosebush, Lynn Sessions, Laura Macherelli and Eric Morris on April 10, 2023 Posted in Alert

The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. The nonbinding guidance, titled “Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act,” stresses the critical need for manufacturers to address … Continue Reading

Staying Ahead of the Curve in Biopharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions

By Winston S. Kirton and Lee H. Rosebush on April 6, 2023 Posted in Podcast

inset glass medicine cabinet in bathroom with door slightly ajar

FDA inspections of biopharmaceutical manufacturers often lead to the discovery of avoidable compliance issues. On today’s episode, Staying Ahead of the Curve in BioPharma: Navigating FDA Inspections, Drug Supply Chain Security Act (DSCSA) Implementation, and Supply Chain Disruptions, we discuss tips for avoiding common compliance issues discovered during FDA inspections and explore the upcoming implementation of … Continue Reading

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