Two SheppardMullin attorneys say the second Warning Letter issued this year by the CDER Office of Prescription Drug Promotion shows the agency is clos...
A bipartisan group of nine members of Congress from Georgia calls for greater FDA transparency on efforts to resolve the current shortage of chemother...
FDA researchers say the agency is working collaboratively to find innovative approaches to optimizing dosages of cancer drugs.
Texas approves a bill to create a program to import drugs from Canada pending HHS approval.
Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) urge FDA commissioner Robert Califf to restrict patents that are listed in the Orange ...
FDA clears an ICU Medical 510(k) for the Plum Duo infusion pump with LifeShield infusion safety software.
Federal Register notice: FDA sends to OMB an information collection extension entitled Customer/Partner Service Satisfaction Surveys.
FDA approves 15 ANDAs representing the first generics of Takedas Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, indicated for at...
