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Patents Supply Shortages Food and Drug Administration (FDA)

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Fuerst Ittleman David & Joseph

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

White & Case LLP

Strong Medicine: Using Investment Treaties to Mitigate Foreign Regulatory Risk in the Life Sciences

White & Case LLP on

The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

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