Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices.
Background -
On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more
New guidance intends to limit product sponsors’ exclusions from the requirement to study pharmaceuticals in pediatric patients.
On December 20, 2017, the US Food and Drug Administration (FDA or Agency) issued draft...more
Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” -
On January 18, 2017, the US Food and Drug Administration (FDA or...more
In new Draft Guidance, FDA revises requirements for manufacturers’ distribution of publications about off-label uses for approved drugs or devices.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Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age.
On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance document providing...more
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