-
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.
-
Jan 13, 2025 | 
today.westlaw.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley
Enter to open, tab to navigate, enter to select
-
Jan 10, 2025 | 
mondaq.com | James Ravitz |Paul S. Gadiock |Jeff Weinstein |Marissa Daley
On December 19, 2024, the US Food and Drug Administration (FDA)issued a new final rule titled "Food Labeling: Nutrient Content Claims; Definitionof Term 'Healthy.'" The rule revises regulationsthat govern when food products may be labeled as"healthy" and when a derivative term (e.g.,"health," "healthful," or"healthier") may be used to make a claim about theproduct's nutritional content.
-
Sep 9, 2024 | 
mondaq.com | James Ravitz |Paul S. Gadiock |Marissa Daley
On August 8, 2024, the US Food and Drug Administration (FDA)
partially revised the availability of certain glucagon-like peptide
1 (GLP-1) medications on the FDA's shortage list.
-
Sep 9, 2024 | 
jdsupra.com | James Ravitz |Marissa Daley |Paul S. Gadiock |Jae Hyun Lee
On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list.
-
Aug 13, 2024 | 
jdsupra.com | Jiayan Chen |Marissa Daley |Paul S. Gadiock
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance.
-
Aug 12, 2024 | 
lexology.com | James Ravitz |Jiayan Chen |Paul S. Gadiock |Jennifer S. Geetter |Jeff Weinstein |Sam Siegfried | +2 more
On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance.
-
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.
-
Jul 16, 2024 | 
jdsupra.com | Jiayan Chen |Marissa Daley |Paul S. Gadiock
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance describes which clinical studies would require diversity action plans, what clinical study sponsors should include in their plans, and when FDA may determine that a sponsor can waive the diversity action plan requirement.
-
Jul 5, 2024 | 
jdsupra.com | Marissa Daley |Paul S. Gadiock |Paul Hughes
The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v. Raimondo, decided on June 28, 2024, held that in deciding whether an agency has acted within its authority under a statute, courts must exercise their independent judgment to determine the best reading of the statute. Loper Bright Enters. v. Raimondo, No. 22-451 (U.S. June 28, 2024).
