Articles related to FDA

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The FDA has issued an alert to healthcare providers to ensure the correct volume of the Moderna COVID-19 vaccine is withdrawn from the vial for children aged six months to 11 years.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.

The FDA’s recent approval of toripalimab, based on the JUPITER-02 and POLARIS-02 clinical trials, marks a significant milestone in the treatment of nasopharyngeal carcinoma. With a median progression-free survival of 11.7 months, toripalimab has shown promising results in improving patient outcomes.

The approval of empagliflozin opens up a new avenue in CKD treatment. With its proven efficacy in reducing the risk of disease progression by 28%, it offers a promising alternative for healthcare professionals dealing with this prevalent condition.