News & Analysis as of

Public Health Manufacturers New Guidance

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

DLA Piper

Industrials Regulatory News and Trends - December 2024 #2

DLA Piper on

California amends Prop 65 short-form warnings. California’s Office of Environmental Health Hazard Assessment has announced long-expected new amendments to its Prop 65 short-form warning requirements. ...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Robinson+Cole Environmental Law +

PFAS Reporting Rules to Ring in the New Year

As we have previously reported, PFAS (per- and polyfluoroalkyl substances) are a class of substances coming under increasing regulatory scrutiny.  As manufacturers ring in the new year they should be aware of two new PFAS...more

Robinson+Cole Manufacturing Law Blog

EPA Establishes New Health Advisories for PFAS

Earlier this month, EPA set new lifetime health advisories for four per- and poly-fluoroalkyl substances (PFAS) – in some instances at levels lower than those that can be detected through laboratory testing. The new health...more

Faegre Drinker Biddle & Reath LLP

FDA Gives Guidance on Reporting Medical Device Shortages

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or...more

Akin Gump Strauss Hauer & Feld LLP

International Trade Impacts of The Coronavirus: Update On Government And Industry Actions And Key Considerations For Trade...

The new coronavirus, SARS-CoV-2, and the disease it causes, COVID-19, have created diverse, complex, and immediate challenges for world governments, multinational businesses, and other international institutions and projects....more

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