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Manufacturers › Manufacturing Facilities › Pharmaceutical Industry

BakerHostetler

FDA’s ‘PreCheck’ Program: New Pathway to Acceleration of US Drug Manufacturing

BakerHostetler on

The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. ...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

Katten Muchin Rosenman LLP on

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

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

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

Carlton Fields on

President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device...

Arnall Golden Gregory LLP on

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Gabe Scannapieco, AGG Litigation & Dispute Resolution partner, to discuss enforcement trends affecting foreign...more

Morgan Lewis - As Prescribed

FDA Embraces Alternative Tools for Inspecting Facilities

Morgan Lewis - As Prescribed on

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more

Goodwin

Navigating the New Normal: Biomanufacturing Goes Local

Goodwin on

The pandemic has spared no industry. As fast-food chains have sought to drive business through chicken sandwich wars, Burger King’s release of its chicken sandwich was delayed in Michigan due to a shortage of pickle jars....more

BakerHostetler

FDA Current Good Manufacturing Practice Inspections During the COVID-19 Pandemic

BakerHostetler on

In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients are involved in the potentially life-saving development of...more

Jones Day

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

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