Federal Register notice: FDA announces that OMB has approved a new information collection entitled Targeted Mechanism of Action Presentations in Presc...
Federal Register notice: FDA issues an order debarring David J. Kempema for five years from importing or offering for import any drug into the U.S.
Pharmaceutical Research and Manufacturers of America calls on FDA to harmonize drug direct manufacturing and point-of-care manufacturing regulation wi...
AdvaMed says it strongly supports FDA efforts to update a guidance on the breakthrough devices program.
Two Hyman, Phelps attorneys say the VALID bill contains what appears to be an inadvertent provision that could adversely affect telehealth testing of ...
FDA approves a Fresenius Kabi BLA for Idacio (adalimumab-aacf), a biosimilar product referencing AbbVies Humira (adalimumab).
A Massachusetts federal judge sentences the former New England Compounding Center operations director to five months in jail for conspiring to defraud...
FDA clears a Life Spine 510(k) for the TruLift Lateral Expandable Spacer System and Lateral Plate System for use in lateral lumbar interbody fusions.
