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The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more

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

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

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