On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs). If enacted, the proposed rule would amend the Agency’s regulations to make
On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous
Final report (online).
The Royal Commission has made 222 recommendations on how to improve laws, policies, structures and practices to ensure a more inclusive and just society that supports the independence of people with disability and their right
The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as
Disregard your Health Insurance Portability and Accountability Act obligations at your own risk.
That’s the stark warning covered entities and business associates should take away from a recent settlement entered into by the nation’s largest publicly operated health plan and
Disregard your Health Insurance Portability and Accountability Act obligations at your own risk.
That’s the stark warning covered entities and business associates should take away from a recent settlement entered into by the nation’s largest publicly operated health plan and
The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other changes, this Final Rule will allow CMS
COMPLIMENTARY WEBINARTuesday, October 24, 202312-1 p.m. (ET) | 11 a.m.-12 p.m. (CT) | 9-10 a.m. (PT)
Join McGuireWoods attorneys Amber McGraw Walsh and Kayla McCann Marty for a discussion of the payor services market. Their webinar will cover:
Arman Oruc joined the Bloomberg Intelligence podcast to share his views on the FTC, and its impact on M&A for the pharma and biotech industry.
Listen to the podcast here.
The post Bloomberg Intelligence – Arman Oruc’s Perspective on the FTC
We’re getting reports of potential canine parvovirus infection in vaccinated dogs in some parts of northern Ontario. Parvo is a nasty but vaccine-preventable disease, and available vaccines are very effective. True vaccine breakthrough (i.e. infection in a fully vaccinated individual)