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Brand Pharmaceutical Industry Food and Drug Administration (FDA)

Mintz - Trademark & Copyright Viewpoints

FDA Issues New Guidance on Drug Naming

Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug...more

Manatt, Phelps & Phillips, LLP

[Webinar] Promotional Review Best Practices: Mitigating Risks, Maximizing Success - September 25th, 1:00 pm ET

How can you reduce conflict on the PRC and work together efficiently across different functions to achieve a common goal? What are the Food and Drug Administration (FDA) regulations you need to keep top of mind when...more

Robins Kaplan LLP

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

Robins Kaplan LLP on

Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more

Dechert LLP

Not All Sunshine and Santa Claus For Generics Post-Mensing

Dechert LLP on

When the Supreme Court decided Mensing, we imagine generic drug manufacturers felt like Stephen Sondheim’s “Everything’s Coming Up Roses” was written just for them. But, to borrow from another Broadway hit, they may now be...more

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