News & Analysis as of

Manufacturers Filing Requirements

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

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Hogan Lovells

FDA clarifies 510(k) clearance transfer rules in new Q&A guidance

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more

Faegre Drinker Biddle & Reath LLP

Comment Period Open for Massive New PFAS Reporting Requirements in Minnesota

On April 21, 2025, the Minnesota Pollution Control Agency (MPCA) issued the proposed PFAS in Products: Reporting and Fees Rule for public consultation. The proposed rule details how the MPCA will require manufacturers to...more

Venable LLP

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

Venable LLP on

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

Fisher Phillips

Snapshot on Manufacturing Industry: 3 Things Employers Need to Know Before Filing Your EEO-1 Reports

Fisher Phillips on

Welcome to this edition of the FP Snapshot Manufacturing Industry, where we take a quick snapshot look at recent significant workplace law developments with an emphasis on how they impact employers in the manufacturing...more

Gardner Law

State Registration Enforcement

Gardner Law on

Are you licensed to sell in these states? Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more

Hinshaw & Culbertson - Health Care

Change is on the Horizon for 340B Pharmacy Program's Administrative Dispute Resolution Process

The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more

K&L Gates LLP

Market Entry and Real World Data – China’s Medical Device Industry

K&L Gates LLP on

The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in...more

Morgan Lewis

Overview of Medical Device Regulation in China

Morgan Lewis on

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Foley & Lardner LLP

Updated TSCA Inventory: What You Need to Know Now to Avoid Business Disruption

Foley & Lardner LLP on

In 2016, after decades without any changes, Congress amended the Toxic Substances Control Act (the “TCSA”) with an eye towards updating and modernizing the regulatory regime for chemical substances. One of the elements of the...more

Morgan Lewis

Reminder: FCC Accessibility Reporting Requirements Due April 1

Morgan Lewis on

The deadline applies to all service providers and equipment manufacturers subject to section 255, 716, or 718 of the Communications Act. Service providers and equipment manufacturers subject to section 255, 716, or 718...more

Williams Mullen

Lesson Learned from EPA Enforcement of EPCRA Form R Requirements

Williams Mullen on

EPCRA § 313 requires certain facilities manufacturing or “processing” more than 25,000 lbs. or otherwise using 10,000 lbs or more of a listed toxic chemical to file a Form R annually on or before July 1. In the last two...more

Akin Gump Strauss Hauer & Feld LLP

Antitrust-Related Recent Developments: DOJ settles gun-jumping case, FTC issues fines for failure to submit HSR filing and FTC...

DOJ fines particleboard manufacturers $4.95 million for gun-jumping violations - On Friday, November 7, 2014, two companies agreed to pay $4.95 million to settle U.S. Department of Justice (DOJ) allegations that the...more

Foley & Lardner LLP

Ten Tips to Develop a Practical Conflict Minerals Approach for 2014

Foley & Lardner LLP on

As you sit at your desk waiting for any guidance regarding what your Conflict Minerals Report should look like, you may allow yourself to think about June 3, 2014, the day after companies are required to file their Form SD...more

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