Opioid Legislation Would Require US FDA Guidance On Non-Opioid Pain Medication Development
Senate HELP Committee unanimously advances bill that would also boost FDA's power over unit dose packaging and improve inspection of international mail facilities.
You may also be interested in...
Lupin Slumps To Q4 Loss Amid US Opioid Action But Build Up In Inhalation, Biosimilars
Lupin ended the fourth quarter in the red hit by an impairment provision related to the "underperforming" assets of its Gavis acquisition but the firm's US inhalation pipeline appears to have made some progress, including a filing for tiotropium dry powder inhaler (DPI). Early stage biosimilars under development include, among others, versions of Neulasta and Xgeva/Prolia.
OTC Monograph Bill Has Energy And Commerce Date, CDER Director's Hope
US House is catching up with Senate on OTC monograph legislation, with a committee markup expected in the next few days.