FDA Releases Draft Guidance for Industry on Biosimilar Interchangeability
On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating…
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U.S. Senators Collins and McCaskill Release Drug Pricing Investigation…
United States Senators Susan Collins (R-ME) and Claire McCaskill (D-MO), the Chairwoman and Ranking Member of the Senate Aging…
Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from…
DOJ may have a new focus for Anti-Kickback Statute violations: care facilities and their owners. This year alone, at least two…
The Trump Administration: One Predictive Perspective
We recently had the pleasure of speaking with Michaeline Daboul, President and CEO of MediSpend, about the upcoming administration…
Co-Payment & Deductible Waivers as Illegal Inducements
Health insurance providers and out-of-network providers, have found themselves in murky water by providing waivers of co-payments,…
Interim FDA Commissioner Announced
Dr. Robert Califf’s tenure as commissioner of the United States Food and Drug Administration (FDA) is slated to come to an end…
FDA Releases Draft Guidance for Medical Product Communications Consistent…
The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
Planning for the Future – HHS OIG’s 2017 Work Plan
Health and Human Services Office of Inspector General has released their 2017 Work Plan. The updated work plan includes some new…
Democrat Senators Send Letter to Trump On Drug Pricing
United States Senators Sherrod Brown (D-OH) and Al Franken (D-MN) led the charge to send a letter to President-Elect Donald Trump,…
U.S. House Introduces Updated Value-Based Incentive Legislation
The House Ways & Means Health Subcommittee recently released updated draft legislation that would establish value-based…