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Life Sciences › Enforcement Actions › Supply Chain

Alston & Bird

FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers

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Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more

DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

DLA Piper on

The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

Foley Hoag LLP

CFIUS Year in Review

Foley Hoag LLP on

CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more

Arnall Golden Gregory LLP

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

Arnall Golden Gregory LLP on

In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

The Volkov Law Group

DOJ Hoarding and Price Gouging Task Force Seizes Critical Medical Supplies and Distributes to New York and New Jersey Hospitals

The Volkov Law Group on

The Justice Department and the FBI have quickly acted to focus on fraudsters and hoarders seeking to profit from the public panic in response to the pandemic.  DOJ issued a memo to U.S. Attorneys prioritizing investigations...more

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