MedPage Today9hOpinion
REMS for Clozapine Must Go
FDA convened a joint meeting of its Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs ...
Medpage Today on MSN2d
Most Clozapine Prescribers Satisfied With REMS Program
Among 196 doctors who prescribed clozapine, 64% said the positive aspects of the REMS certification process outweighed the ...
STAT9d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
pharmaphorum2d
FDA decisions on treatments for gastrointestinal disorders
The role of the Gastrointestinal Drugs Advisory Committee (GIDAC) is to review and evaluate available data ‘concerning the safety and effectiveness of marketed and investigational human drug ...
EurekAlert!3d
SHEA supports key federal advisory committees
The Society for Healthcare Epidemiology of America (SHEA) urges incoming Secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., to resume the federal advisory committees ...
Medscape9d
In the Pipeline: FDA Advisory Committee Reviews - June 2004
Date and FDA Advisory Committee. June 2, 2004 meeting of the Arthritis Advisory Committee. Subject. Clinical trial designs and endpoints for drugs for chronic gout, including new drug application ...
Medscape26d
In the Pipeline: FDA Advisory Committee Reviews
Date and FDA Advisory Committee: May 6, 2004 joint meeting of the Nonprescription Drugs Advisory Committee and the Dermatologic & Ophthalmic Drugs Advisory Committee. Subject: Efficacy and ...