By James C. Shehan – Of the three FDA final guidances that FDA recently released (here, here and here), the Questions and Answers guidance has received the most attention (see our previous post here). But our perusal of the ScientificConsiderations in Demonstrating Biosimilarity to a Reference …
By Kurt R. Karst – FDA’s Sixth Annual Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience during Fiscal Year 2013 (“FY 2013”) with citizen petitions subject to FDC Act § 505(q), though largely repetitive of reports filed for previous fiscal years …
By Jennifer M. Thomas & Anne K. Walsh – French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.” The first suit, as readers may recall (see our previous post here), resulted in a finding from …
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) recently revised its Standard Operating Procedures and Policies (“SOPP”) concerning review of orphan drug designation requests to provide the Office’s policies on designating products for two diseases: scleroderma and pulmonary hypertension. The second version …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Jennifer M. Thomas & Anne K. Walsh – Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a …
