Jill Wechsler is BioPharm International's Washington editor.
Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
PhRMA report reflects robust R&D in vaccine development.
Manufacturing standards are considered key to preventing drug recalls and shortages.
Updates on user fees, heparin supply concerns, orphan drug incentives, REMS updates, reference standards for proteins, and patent settlements.
New FDA supply chain policies aim to strengthen inspection and oversight processes.
FDA funds research to further development of innovative generics, while working to address review and approval issues.
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.