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Manufacturers › FDA Approval › Supply Chain

BakerHostetler

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

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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

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Emergency Use Authorization for Ventilators, Tubing Connectors and Accessories

Faegre Drinker Biddle & Reath LLP on

The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as...more

Morgan Lewis

FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products

Morgan Lewis on

In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more

Hogan Lovells

FDA moves to increase ventilator supply

Hogan Lovells on

Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more

Foley & Lardner LLP

Manufacturing MarketTrends - July 2019, Issue 2

Foley & Lardner LLP on

Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more

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