06/22/2012 - 8:19am

The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

06/21/2012 - 2:22pm

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.

06/21/2012 - 10:51am

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.

06/21/2012 - 10:50am

The leader of the country’s largest privately owned specialty pharmacy provider had a day in Washington.

06/21/2012 - 10:50am

In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds.

06/21/2012 - 10:49am

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.

06/21/2012 - 10:49am

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. 


06/21/2012 - 10:47am

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. 


06/21/2012 - 10:47am

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.