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Regulatory Requirements › Supply Chain › FDA Approval

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

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...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

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