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Food and Drug Administration (FDA) › Exclusive Use

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

FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

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

The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more

Foley & Lardner LLP

FDA to Give 5 Year NCE Exclusivity to Combinations

Foley & Lardner LLP on

In a Federal Register Notice dated February 24, 2014, the U.S. FDA announced a draft guidance for industry that will provide a 5 year NCE exclusivity period to fixed-combination drug products that include at least one new...more

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