Warning Letter Roundup & Recap – July 2022
A manufacturer and importer of COVID-19 tests was cited for distributing unauthorized devices as well as GMP violations in the only warning letter issued to a medtech company last month.
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One-Page Patient Medication Information Document Moves Forward Under Proposed Rule
After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.
Japan Eyes Cutting Reimbursement For COVID-19 Drugs
Japan will end full reimbursement coverage for COVID-19 therapeutic drugs from October, after downgrading the status of the virus to the same level as seasonal flu in early May. As authorities discuss the possible coverage reduction, a larger than usual price cut may also be applied to Shionogi's oral COVID antiviral Xocova.
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
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