Healthcare IT Today

FEBRUARY 28, 2023

He reported poor standardization of data coming out ot at test centers, despite the standards for interoperability delineated in the Health Information Technology for Economic and Clinical (HITECH) Act of 2009. For data reporting, Diameter Health improved lab data to adhere to standard and interoperable formats.

Public Health 101

Public Health COVID-19 FDA Governance 101

Drug & Device Law

FEBRUARY 25, 2022

case ( Conte ) in 2009. allegations of failure to report adverse events to the FDA. This talc-related petition for certiorari raised two preemption issues of general importance: abolition of the presumption against preemption and what constitutes “official,” preemptive FDA action. The appeal remains pending. SC20607 (Conn.

FDA 59

FDA 59

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

FDA 52

FDA Governance 52