FDA Releases Draft Guidance on Indications and Usage Labeling Sections
On July 9, 2018, the United States Food and Drug Administration (FDA) issued draft guidance entitled, “Indications and Usage…
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July 2018
2019 CMS Proposed Physician Fee Schedule Includes Serious Cuts to Medicare…
On July 12, the Centers for Medicare & Medicaid (CMS) released its proposed Medicare Physician Fee Schedule for 2019. The…
Lawsuit Filed Over New York Opioid Tax and Stewardship Law
Recently, the Healthcare Distribution Alliance filed a federal complaint in the Southern District of New York, arguing that the…
FDA Releases Final Guidance on Medical Product Communications and Labeling
Recently, the United States Food and Drug Administration (FDA) released “Medical Product Communications That Are Consistent With…
Consultant Found Guilty Using CMS Data for Insider Trading
Washington, D.C. based consultant David Blaszczak was convicted and found guilty of stealing secrets from the government and…
Subcommittee on Health to Hold Hearing on Reforming the 340B Drug Pricing…
The House Energy and Commerce Subcommittee on Health announced they will hold a hearing on Wednesday, July 11, 2018, at 10:00…
CMS Releases FY 2019 IPPS and PTCH PPS Proposed Rule
Recently, the Centers for Medicare & Medicaid Services (CMS) released its fiscal year (FY) 2019 inpatient prospective payment…
FDA Publishes Draft Guidance on Expanding 510(k) Pathway
A draft guidance recently issued by the United States Food and Drug Administration (FDA) sets the stage for how an existing 510(k)…
Azar Continues to Promote Administration Drug Pricing Policy, Plus RFI…
On June 26, 2018, the Senate Finance Committee held a hearing to examine President Donald Trump’s plan to lower prescription drug…
Open Payments Data 2017: Significant Drop in Number of Payments
On Friday, June 29, 2018 the Centers for Medicare & Medicaid Services (“CMS”) released the 2017 Open Payments Data, which…