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Government Agencies
HHS Final Rule a Win for Copay Accumulator Adjustment Programs
On May 14, 2020 the Department of Health and Human Services (HHS) finalized the Notice of Benefit and Payment Parameters for 2021…
DEA Amends Regulations Applicable to Registrants Ordering Certain…
Last month, the Drug Enforcement Administration (DEA) published a notice in the Federal Register that it is amending its…
OPDP to Study Physicians’ Interpretations of Drug Information
Recently, the United States Food and Drug Administration (FDA) announced its Office of Prescription Drug Promotion (OPDP) plans to…
Three Pharma Companies Sue HHS, Judge Rules in Their Favor
In June 2019, several drug manufacturers filed a lawsuit against the United States Department of Health and Human Services (HHS)…
The End of Guidance Documents or Simply a Reminder of Well-Established…
As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing…
New Limitations on Guidance Documents Expected to Have Heavy Effect on…
The Trump Administration recently adopted new limits on the use of “guidance documents” issued by federal agencies. Various…
State of the Union De-Briefing
President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he…
Trump Nominates Alex Azar to Head HHS
A few weeks ago, President Donald Trump nominated Alex Azar to lead the Department of Health and Human Services (HHS), following…
Hospitals and Health Systems Sue CMS Over 340B Provisions
Three hospital groups, along with three health systems, have filed suit against the Department of Health and Human Services (HHS)…
FDA Releases Draft Guidance for Industry: Statistical Approaches to…
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft…