Articles related to FDA

The FDA’s 2024 agenda navigates the complexities of AI, cybersecurity, and emergency use authorizations, setting the stage for a transformative era in medtech.

The therapy aims to restore progranulin protein levels in the brain, marking a significant step forward in the treatment of neurodegenerative disorders.

The FDA’s guidance on psychedelic medicine is a landmark in mental health treatment. With the potential to treat PTSD, addiction, and treatment-resistant depression, psychedelics could heighten the field. However, the guidance also highlights the need for rigorous study of these substances, particularly regarding their subjective effects and the role of psychological support.

The “revolving door” phenomenon, exemplified by the transition of Doran Fink from the FDA to Moderna, raises critical questions about public trust and regulatory integrity. As healthcare professionals, understanding these dynamics can inform our perspectives on regulatory processes and pharmaceutical industry relationships.

The FDA has issued an alert to healthcare providers to ensure the correct volume of the Moderna COVID-19 vaccine is withdrawn from the vial for children aged six months to 11 years. This comes amid reports of double doses being administered to children, emphasizing the importance of precise dosage in vaccine administration.

The FDA’s recent warning about compounded ketamine products underscores the need for rigorous clinical studies to investigate ketamine’s benefit-risk profile and safe-use conditions in the treatment of psychiatric disorders.