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Clinical Trials › Appeals › Food and Drug Administration (FDA)

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

Fish & Richardson on

The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

McDermott Will & Schulte

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Schulte on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Foley Hoag LLP

Product Liability Update - April 2025

Foley Hoag LLP on

Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

Smart & Biggar on

Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Farrell Fritz, P.C.

NY Court of Appeals Rejects Hospital’s Bid To Cloak Allegedly Defamatory FDA Investigation Statements With Absolute Immunity

Farrell Fritz, P.C. on

The recent New York Court of Appeals decision in Stega v. New York Downtown Hospital provides strong support for defamation claims arising out of witness testimony in investigations and quasi-judicial hearings....more

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