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The Supreme Court has construed the safe harbor to apply to drugs as well as medical devices and other products subject to Food and Drug Administration (FDA) approval. [read post]
7 Jul 2015, 1:55 pm
Food and Drug Administration for approval to market a generic version of Lilly's Axiron product constitutes patent infringement. [read post]
25 Jun 2013, 9:51 am by Sheppard Mullin
Actavis, Solvay Pharmaceuticals filed a New Drug Application for a brand-name drug called AndroGel.[3] The Federal Food and Drug Administration (“FDA”) approved the application in 2000. [read post]
7 Dec 2017, 4:23 am by Edith Roberts
” Subscript’s graphic explainer is here. [read post]
28 Apr 2022, 4:17 pm by Coral Beach
The document, sent to top officials at the Food and Drug Administration in October 2021, sparked outrage from U.S. [read post]
25 Jan 2007, 12:48 am
Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act.Martin v. [read post]
2 Nov 2012, 11:58 am by Bexis
 And here are a few more below the state supreme court level:Gajewsky v. [read post]
28 Oct 2015, 4:30 am
  Behold its splendor and majesty: "In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and… [read post]
21 Apr 2023, 1:30 pm by Lawrence Solum
Food and Drug Administration (FDA) contribute to disparities in health-care access and outcomes. [read post]
23 Sep 2011, 2:59 am
Here is her summary:The FDA and ImportsThe Food and Drug Administration (FDA) is responsible for ensuring that imported foods are safe and that unsafe imported foods will not reach consumers.[1]   Under the Food, Drug, and Cosmetic Act (FD&C Act), FDA has the authority to prevent the admission of any imported products that violate the Act. [2] Refusing Entry after InspectionFDA has the power to refuse admission of… [read post]