Baxter International recalls one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100 mL, after it was exposed to subfreezing temperature...
CDER publishes a new Manual of Policies and Procedures (MAPP 5200.12) on Communicating Abbreviated New Drug Application Review Status Updates with Ind...
FDA awards 15 new clinical trial research grants totaling more than $22 million to advance product development for patients with rare diseases.
FDA continues working with Puerto Rico-based manufacturing facilities to restore their capacity in order to prevent possible medical product shortages...
A FY 2017 CBER recall posting report details an 11% increase in total recalls over FY 2016.
The ACLU files suit against FDA REMS restrictions on access to the Mifeprex abortion pill.
Attorney JP Ellison says a Massachusetts federal court ruled that suits challenging dispensers for prescription eye drops were preempted because the m...
FDA Office of Minority Health director Jonca Bull leaves FDA to join Pharmaceutical Product Development in a dual role as head of regulatory consultin...