In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.
On March 3, 2014, the Food and Drug Administration (FDA) released a...more
Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age.
On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more
Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action.
The US Food and Drug Administration (FDA or...more
What is new in the world of follow-on biologics?
Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for...more
FDA report demonstrates support for personalized medicine and more efficient regulatory pathways.
In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more