Import Alert: FDA Working Toward Consistency, Better Decision Making
This article was originally published in The Tan Sheet
FDA’s broad reorganization might not create for the import staff the same super-specialization coming to other parts of the agency, but a process overhaul appears on its way regardless.
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The Trusted Trader program would create some incentives to companies willing to ensure their supply chains are secure, but is similar to a program FDA already has in place.
PREDICT eventually will help low-risk importers because data will drive the system to not flag those firms, easing the import process. Firms should work hard to stay off the import alert list, which prompts closer scrutiny and can lead to delays.
Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.