Jill Wechsler is BioPharm International's Washington editor.
New identifiers and tracking requirements aim to block illegitimate products.
Accelerated testing and production create challenges in documenting product quality.
FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.
Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.
OGD is under pressure to improve review operations.
FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
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.