Ciba-Geigy Vioform-hydrocortisone DESI hearing
Executive Summary
Fifth day of testimony was heard Nov. 18 from Ciba-Geigy witnesses, Howard Maibach, MD, University of California, San Francisco, and Henry Jolly, MD, Louisiana State University. According to Ciba-Geigy, the two dermatologists confirmed "their previous testimony that the efficacy of this combination product had been demonstrated by several adequate and well controlled clinical trials." The hearing began Nov. 6 and is scheduled to conclude on Dec. 4.
You may also be interested in...
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.
Drug Shortages, Inspections In Focus At US FDA Appropriations Hearing
Commissioner Robert Califf discussed the agency’s request for $12.3m to address shortages and legislation to require that manufacturers provide more detailed information about increased demand and supply chain vulnerabilities.