Jill Wechsler is BioPharm International's Washington editor.
The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Demand for new therapies and vaccines spotlights production challenges.
FDA demands accurate manufacturing and test information to ensure product quality.
Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.
Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.
Supplier Audit Program Marks Progress