The Quality Lowdown: Foreign Burden, Border Destruction, Particles, Sterility
FDA asks about regulating foreign firms more and destroying drugs at the border, and questions firms about particles and aseptic practices.
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Numerous value frameworks launched over the past few years have encouraged acceptance of cost effectiveness assessments in the US and ICER's influence in the field is growing. Employers may be the next group to promote the concept.
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.
Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.