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Food and Drug Administration (FDA) › 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

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

Bricker Graydon LLP

2022 Medicare OPPS/ASC Proposed Rule includes updated reimbursement rates, new policies, and reversals of recent policy changes

Bricker Graydon LLP on

On July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the Calendar Year (CY) 2022 Hospital Outpatient Prospective System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule (Proposed Rule). In...more

Mintz - Health Care Viewpoints

Bioethics in a Pandemic: FDA Guidance on Granting EUAs for a COVID-19 Vaccine

Mintz - Health Care Viewpoints on

Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...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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