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Highlights and Commentary from the FDA's Public Workshop on Proposed Framework for Regulatory Oversight of Laboratory Developed...

On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more

1/16/2015 - FDA Laboratory Developed Tests Proposed Regulation Regulatory Agenda

USPTO Issues New Guidance with Fewer Limitations on the Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed...more

12/17/2014 - Alice Corporation CLS Bank v Alice Corp DNA Mayo v. Prometheus Myriad Myriad-Mayo Patent-Eligible Subject Matter Patents Product of Nature Doctrine USPTO

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

8/7/2014 - Clinical Laboratories Enforcement Guidance FDA Laboratory Developed Tests Medical Devices

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

5/1/2014 - Digital Health Healthcare IPO Patents SBIRs Startups Venture Funding

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

2/27/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

The Life Sciences Report - Spring 2013

In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more

6/12/2013 - America Invents Act Civil Monetary Penalty CMS Final Rules Mayo Foundation for Medical Ed Mayo v. Prometheus Patent Reform Patents Sunshine Act Venture Capital

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