Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Efforts to accelerate drug development will alter fee structure and require ready production sites.
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
This key bioprocessing segment is expecting continued growth.
The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.