By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had already passed the House on October 28, and is expected to be signed imminently by the …
Menu
Product Jurisdiction and Combination Products
- Bipartisan Budget Bill Extends Medicaid Drug Rebate Program Price Increase Penalty to Generic DrugsNovember 2nd, 2015
- No More Scarlet Letter: FDA’s Scientific Considerations Biosimilars Guidance Clarifies, Adds and Subtracts Various Approval Requirements, But Perhaps the Most Significant Change is to Biosimilar LabelingMay 14th, 2015
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 …
- FDA’s Sixth Annual Report to Congress on 505(q) Citizen Petitions: Agency Says Provision Has Not Been Effective in Curbing Frivolous PetitionsDecember 31st, 2014
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 …
- Court Vacates FDA’s Classification Decision (Again)September 9th, 2014
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 …
- OOPD Clarifies Orphan Drug Designation Policies for Scleroderma and Pulmonary HypertensionJanuary 15th, 2014
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 …
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
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, …
- Is it a Drug or Device? Court Requires FDA to Explain ItselfSeptember 26th, 2012
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 …