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Pharmaceutical Industry › Proposed Rules › Biologics

Benesch

CMS Proposes Overhaul of Skin Substitute Reimbursement Policy Beginning January 2026 - Implications for Providers, Manufacturers,...

Benesch on

On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Troutman Pepper Locke

FDA Proposes New Rules for Prescription Drug Labeling

Troutman Pepper Locke on

On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

Hogan Lovells

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts...

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling...more

Epstein Becker & Green

CMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 2020

Epstein Becker & Green on

On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”)....more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

Epstein Becker & Green on

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

McDermott Will & Schulte

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

McDermott Will & Schulte on

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

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