OR WAIT null SECS
Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
November 02, 2012
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
October 09, 2012
A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stronger FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention reported seven deaths and 91 ill.
A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities.
October 04, 2012
The heavy buzz at the recent fall technical conference sponsored by the Generic Pharmaceutical Association (GPhA) involved proposals for reorganizing the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER).
October 02, 2012
The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.
September 25, 2012
Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA).