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Pharmaceutical Industry › Food and Drug Administration (FDA) › Marketing Exclusivity Periods

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

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

Hatch-Waxman goes to Taiwan

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

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms. The amended Act is expected to come into effect in late 2018 or early 2019....more

Patterson Belknap Webb & Tyler LLP

FDA Approves the First Gene Therapy to Treat an Inherited Disease

Patterson Belknap Webb & Tyler LLP on

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more

Foley & Lardner LLP

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

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