FDA Issues Draft Guidance on Decentralized Clinical Trials
Recently, the United States Food and Drug Administration (FDA) issued a Draft Guidance, “Decentralized Clinical Trials for Drugs,…
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OPDP Untitled Letters Are Back
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent its first untitled…
Transparency, Aggregate Spend & HCP Engagement 2023
Transparency, Aggregate Spend & HCP Engagement is the leading event for life science companies to keep up to date on current…
PatientView Releases 2022 Patient Group Survey on Pharmaceutical Industry
Recently, PatientView released its Corporate Reputation of Pharma survey results, which found that more than half of patient…
SCOTUS Affirms DOJ’s Right to Dismiss Qui Tam Suits
On June 16, 2023, the United States Supreme Court affirmed that the Department of Justice (DOJ) has the authority to dismiss qui…
CMS Issues Prospective Payment System Proposed Rule for FY 2024
On April 10, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH)…
Notice of Benefit and Payment Parameters for 2024 Issued by CMS and HHS
On April 17, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the U.S. Department of Health and Human…
CMS Issues Final Rule, Making changes to MA and Part D
In April, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule regarding the Medicare Advantage (MA) and…
21st Century Cures Act Proposal Issued
The federal government's healthcare tech arm released proposed provisions of the 21st Century Cures Act and enhancements to the…
Merck Sues to Stop Drug Price Negotiation Program
Recently, Merck & Co sued the United States Department of Health and Human Services (HHS) and Centers for Medicare and…