Karis Jackson

2 months ago | lexology.com | James Ravitz |Paul S. Gadiock |Michael Ryan |Jeff Weinstein |Marissa Daley |Karis Jackson | +2 more

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however.

Jul 31, 2024 | jdsupra.com | Marissa Daley |Paul S. Gadiock |Karis Jackson

Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that are not. Such misinformation is especially harmful when it is shared by an internet user with a large following or someone who holds a position of trust, and when the misinformation relates to medical products that treat or prevent serious or life-threatening diseases.

May 30, 2024 | jdsupra.com | Marissa Daley |Paul S. Gadiock |Karis Jackson

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the first step to easing federal restrictions on cannabis and potentially opening up the door for further cannabis research and development.

May 29, 2024 | lexology.com | James Ravitz |Alva C. Mather |Paul S. Gadiock |Deepika Raj |Marissa Daley |Karis Jackson

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the first step to easing federal restrictions on cannabis and potentially opening up the door for further cannabis research and development.

Mar 26, 2024 | lexology.com | James Ravitz |Paul S. Gadiock |Rachel Gartner |Marissa Daley |Karis Jackson

On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements navigate the process of submitting new dietary ingredient notifications (NDINs) to the FDA.