Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.
Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics supplemental NDA for Ty...
A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signaling interest but not ...
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 ...
