Compounding Deal In Congress Allows Voluntary FDA Oversight Of Large-Scale Facilities
This article was originally published in The Pink Sheet Daily
Compounders could submit to inspections, user fees and adverse event reporting, providing potential market advantage; Legislation, which includes track and trace draft bill, avoids compounding controversies and could be poised for swift passage.
You may also be interested in...
US agency's budget authority would remain at current level under FY 2018 appropriations bill reported out by a House subcommittee; measure includes language enabling FDA's Oncology Center of Excellence to receive 21st Century Cures funding transferred from National institutes of Health.
Batch failure and other measures commonly tracked by manufacturers could be aggregated into an industry-wide index that FDA would use to help make risk-based inspection decisions.
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.