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Compliance Regulatory Requirements Manufacturers

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

Paul Hastings LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Farella Braun + Martel LLP

Legislation Banning “Forever Chemicals” in Food Packaging in California by 2028 Will Likely Become Law

The California Senate recently passed a bill, SB 682, that would essentially eliminate the use of per-and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” in food packaging within the state, as of January...more

Shook, Hardy & Bacon L.L.P.

Material Concerns: Legal Updates on Substances of Emerging Concern

First effective in 2024, the Act bans the sale or distribution of various products that contain intentionally added PFAS chemicals. On January 1, 2026, as part of the product phase-out timeline, the new law bans the sale or...more

DLA Piper

Producer Obligations Under EPR Laws: Exploring Alternatives to PRO Participation

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A defining feature of the extended producer responsibility (EPR) laws emerging across the United States is the expectation that producers join a statewide producer responsibility organization (PRO). But for some producers,...more

DLA Piper

FAA Issues Final MOSAIC Rule: Key Updates and Changes

DLA Piper on

The Federal Aviation Administration (FAA) released an unpublished version of the Modernization of Special Airworthiness Certification (MOSAIC) rule on July 22, 2025. The rule will become effective 90 days after publication in...more

Bergeson & Campbell, P.C.

Prop 65 “Short Form” Warning Requirements — A Conversation with Lisa R. Burchi

This week, I sat down with Lisa R. Burchi, Of Counsel to Bergeson & Campbell, P.C. and resident expert on Proposition 65, among many other chemical laws. Lisa explains why businesses doing business in California need to know...more

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

Gardner Law on

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 15, 2025)

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FTC Sends Warning Letters Regarding Potential Noncompliance With “Made in USA” Requirements. On July 8, the FTC sent letters to a flagpole retailer, footwear maker, football equipment company, and personal care products...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – July and August Filings - 2025

Manufacturers of wireless handsets that are used in the delivery of digital commercial mobile radio service within the scope of FCC Rule 20.19 are required to file information annually regarding their compliance with the...more

McGlinchey Stafford

EPA Grants Two-Year Extension on Coke Oven Air Toxics Compliance Following Industry Input

McGlinchey Stafford on

The U.S. Environmental Protection Agency (EPA) has officially extended key compliance deadlines for air toxics standards affecting steel-sector coke oven operations, reflecting industry concerns about the feasibility of...more

Davis Wright Tremaine LLP

European Accessibility Act Goes Live

As of June 28, 2025, enforcement of the European Accessibility Act (EAA or the Act) can officially begin, marking a significant milestone for digital accessibility in the European Union (EU). The EAA establishes comprehensive...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Gardner Law

What to Do When FDA Detains Your Shipment

Gardner Law on

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Morrison & Foerster LLP

German Accessibility Act Comes into Force

Individuals with disabilities face numerous challenges when accessing digital services and products, encountering significant barriers in their daily lives. The German Accessibility Act (Barrierefreiheitsstärkungsgesetz,...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

King & Spalding on

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

DLA Piper

Single-Use Plastics Fund Act: Original Reporting Deadline Passed – Act Now for Extended Date

DLA Piper on

Germany’s Single-Use Plastics Fund Act (EWKFondsG) requires manufacturers to report 2024 data on single-use plastic products. The original 15 May 2025, deadline has passed, but the Federal Environment Agency (UBA) has...more

Kelley Drye & Warren LLP

Reminder: Federal Communications Commission – June and July Filings

Carriers and providers of interstate and international telecommunications that seek to revise their May 1, 2025, Form 499-Q filing must do so within 45 days of the Form 499-Q filing deadline, i.e., by June 16, 2025 (because...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

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