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Articles 1 - 4 of 4
Full-Text Articles in Food and Drug Law
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
Other Publications
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely
Other Publications
The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
The Meningitis Outbreak: Don't Expect Miracles From The Fda, Joanne Doroshow
Other Publications
The good news for states is drug industry immunity only kicks in if the drugs in question are FDA-approved. And thanks to the first-rate influence-peddling and lobbying prowess of compounding pharmacists, the tainted steroid shots at issue today are free and clear of FDA regulation.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …