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Regulatory Requirements Reporting Requirements Pharmaceutical Industry

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

Ropes & Gray LLP on

The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

Hogan Lovells on

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Goodwin

State Drug Transparency Laws - 2025 Update

Goodwin on

We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Smart & Biggar

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and...

Smart & Biggar on

On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more

ArentFox Schiff

Massachusetts Enacts Drug Pricing Legislation: Introducing PBM Licensure, Mandatory Cost Reporting, and Consumer Cost-Sharing...

ArentFox Schiff on

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Blake, Cassels & Graydon LLP

Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more

BCLP

HFC Regulation: Navigating Impacts to a Fast-Growing “Climate Control” Industry

BCLP on

Climate control technology is increasingly a focal part of modern society’s expectation to have sophisticated supply chains, particularly relating to perishable items such as pharmaceuticals, raw products, and food. ...more

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Bass, Berry & Sims PLC

Massachusetts HB5159 Expands Oversight of Private Equity Investment in the Health Care Industry

Bass, Berry & Sims PLC on

On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more

Epstein Becker & Green

Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill

Epstein Becker & Green on

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last...more

Polsinelli

Massachusetts Issues Additional Update to Non-Resident Pharmacy Rules

Polsinelli on

Following the release of a memo last month detailing upcoming regulations, the Massachusetts Board of Registration in Pharmacy released its long-awaited regulatory changes for non-resident pharmacy licensure last week by...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

Quarles & Brady LLP on

On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

ArentFox Schiff

New Burdensome FDA Requirements Mandate Reporting Volumes of Almost All Drugs Produced Each Year

ArentFox Schiff on

On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more

Polsinelli

OIG Issues Guidance on Speaker Programs By Drug and Device Companies

Polsinelli on

This week, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert providing insight into speaker programs put on by drug and medical device companies that the OIG considers signs of potential fraud. Generally,...more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: CFIUS reporting obligations

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

Hogan Lovells on

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

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