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Biologics New Regulations

Rothwell, Figg, Ernst & Manbeck, P.C.

Patent Listings and Other Information Coming to the Purple Book

The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food...more

Goodwin

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

Goodwin on

Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

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