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Regulatory Requirements Executive Orders Manufacturers

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Cooley LLP

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

Cooley LLP on

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

Morgan Lewis on

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more

McGuireWoods Consulting

White House Issues Executive Order to Promote Domestic Prescription Drug Manufacturing

On May 5, 2025, President Trump signed an executive order designed to increase U.S. capacity to manufacture drugs domestically. The order instructs the Food and Drug Administration (FDA) to...more

Bergeson & Campbell, P.C.

Chemical Companies Petition EPA to Amend TSCA Section 8(a)(7) PFAS Reporting Rule

On May 2, 2025, a coalition of chemical companies petitioned the U.S. Environmental Protection Agency (EPA) for an amendment of the Toxic Substances Control Act (TSCA) Section 8(a)(7) rule requiring reporting for per- and...more

Warner Norcross + Judd

Tariff Changes — Automotive Offsets and Tariff Stacking

Through an executive order and a proclamation, both issued on April 29, 2025, President Donald Trump revised the application of previously announced tariffs, including those impacting automobiles and automobile parts. In his...more

Brooks Pierce

PFAS Regulatory Developments and Risk Considerations for Manufacturers 

Brooks Pierce on

I. Overview of Federal Regulatory Developments Related to PFAS - Federal government activities with respect to regulation of PFAS in 2021, which will likely carry forward through 2024 include the following: ...more

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