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Regulatory Requirements Regulatory Oversight Imports

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...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

Morgan Lewis

Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development

Morgan Lewis on

With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts...more

Troutman Pepper Locke

ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

Troutman Pepper Locke on

Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an...more

Hogan Lovells

Senate passes online country of origin labeling requirements under the USICA

Hogan Lovells on

On 8 June 2021, the Senate passed the U.S. Innovation and Competition Act (USICA), which contains a wide range of provisions aimed at improving the United States’ global economic competitiveness, particularly toward China. ...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | April 2020

What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more

Robins Kaplan LLP

Financial Daily Dose 12.04.2019 | Top Story: Google Co-founders Step Down From Executive Roles at Parent Alphabet

Robins Kaplan LLP on

Google announced late Tuesday that co-founders Larry Page and Sergey Brin are “stepping down from executive roles at Google’s parent company, Alphabet.” Google CEO Sundar Pichai will now helm both operations, while Page and...more

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

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The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

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The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

Hogan Lovells

FDA Releases Strategy for the Safety of Imported Food

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

Hogan Lovells

What would a no-deal Brexit look like for the UK chemicals industry?

Hogan Lovells on

The UK government has recently published a technical notice to guide businesses that produce, register, import or export chemicals on what they will need to do if the UK leaves the EU in March 2019 in a 'no deal' scenario...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2018

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Modernization for Dairy Product Identities - Following his related statements at a conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has...more

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