A diagnostic test designed to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever has been approved by the Food and Drug Administration, the Centers for Disease Control and Prevention announced Thursday.
Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.
Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like.
Currently there are two overarching legislative issues that either threaten to place greater restrictions on certain over-the-counter medicines or fail to restore access to an OTC benefit that once played a significant role in helping develop interest in the flexible spending account plans available today.