Study faults FDA approval process
Seventy-nine percent of drugs and medical devices are approved by the FDA's outside advisory panels, according to a study conducted by National Research Center for Women & Families. The Washington-based nonprofit research group termed the committees as little more than "rubber stamps" for drug companies.
Study faults FDA approval process
Seventy-nine percent of drugs and medical devices are approved by the FDA's outside advisory panels, according to a study conducted by National Research Center for Women & Families. The Washington-based nonprofit research group termed the committees as little more than "rubber stamps" for drug companies. The study looked at 89 applications between 1998 and 2005 that were considered by 11 randomly selected advisory committees. In July the FDA announced it would take steps to strengthen the advisory committee processes with guidelines for "greater clarity and transparency" to reassure the public about the basic integrity of the process.
To see more Hot off the Press news articles, click here http://www.drugtopics.com/Hot+off+the+Press.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
