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Ripeness Pharmaceutical Industry

Quarles & Brady LLP

Federal Court Deals Blow to FDA’s Compounding MOU

Quarles & Brady LLP on

On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more

Dechert LLP

District of Delaware Holds that ANDA Filer’s Conversion from a PIV Certification to a PIII Certification Does Not Strip Court of...

Dechert LLP on

Generic manufacturers seeking to put an end to Hatch-Waxman Act patent litigation over a branded company’s Orange Book-listed patents can seek to do so by converting from Paragraph IV (“PIV”) patent certifications to...more

Farrell Fritz, P.C.

Commercial Division Denies Pfizer's Motion To Dismiss, Holds Allergan's Claims for Defense Costs Are Ripe

Farrell Fritz, P.C. on

It’s back to business as usual for Commercial Division Justice Andrew Borrok, who recently issued a slew of decisions contributing to New York’s robust Commercial Division jurisprudence.  ...more

Farrell Fritz, P.C.

Commercial Division Denies Pfizer’s Motion To Dismiss, Holds Allergan’s Claims for Defense Costs Are Ripe

Farrell Fritz, P.C. on

It’s back to business as usual for Commercial Division Justice Andrew Borrok, who recently issued a slew of decisions contributing to New York’s robust Commercial Division jurisprudence....more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

Mintz - Health Care Viewpoints

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

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