News & Analysis as of

FDA Approval Patent Litigation Federal Food Drug and Cosmetic Act (FFDCA)

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more

Foley & Lardner LLP

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

Foley & Lardner LLP on

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

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