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Pharmaceutical Industry › 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

Alston & Bird

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

Alston & Bird on

In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...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

Seyfarth Shaw LLP

Chinese Manufacturers of Personal Protective Equipment Gave False U.S. Agent Information to Food and Drug Administration

Seyfarth Shaw LLP on

U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more

American Conference Institute (ACI)

[Webinar] Examining the COVID-19 Effect on the Business and Practice of Hatch-Waxman Litigation - June 2nd, 12:00 pm - 1:00 pm EST

American Conference Institute (ACI) on

The coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry. To help you carve out a path forward, in-house senior executives and industry leaders will convene virtually at ACI’s...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

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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