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AHA comments on blood glucose monitoring test systems guidance
The Food and Drug Administration’s draft guidance on blood glucose monitoring test systems for prescription point-of-care use would appropriately improve the safety and efficacy of the devices while recognizing their vital role in hospitals and health systems, AHA said in comments submitted yesterday.
CMS explains hospital outreach laboratory data reporting obligations
The Centers for Medicare & Medicaid Services has released updated resources intended to clarify whether a hospital outreach laboratory qualifies as an “applicable laboratory” under the Medicare Clinical Laboratory Fee Schedule and detailing related requirements for collecting and reporting private-payer rate clinical laboratory test payment and volume data.
FDA issues warning about prescription drug provider
The Food and Drug Administration yesterday issued a warning letter to CanaRx, a company that contracts with employers to provide select prescription drugs to employees, for facilitating the distribution of unapproved and misbranded drugs.