OR WAIT null SECS
Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.
December 01, 2014
Sponsor response to FDA's breakthrough program has exceeded FDA expectations, but puts pressure on manufacturers to address formulation, stability and quality production issues very early in development.
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
November 20, 2014
The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.
November 05, 2014
The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.
November 04, 2014
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers.
November 02, 2014