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Category Archives: Products Liability
The FTC Appeals Shire ViroPharma Dismissal
By Jennifer M. Thomas — Declaring its intent to stand on the original complaint in FTC v. Shire ViroPharma, the FTC has appealed the District Court for the District of Delaware’s decision to dismiss the Commission’s unfair competition case against Shire without prejudice. We previously blogged about this case here, and here. Although District Court dismissals without prejudice are typically not subject to immediate appeal, the FTC seeks appellate jurisdiction by declaring that it will not amend its original Complaint despite the District Court’s grant of leave to do just that. Rather, the FTC will risk abandoning its case in District Court in favor of seeking a review of the key legal issue by the Third Circuit. This speaks to the significance of the lower court’s ruling that the FTC had failed to meet its statutory burden in bringing the case – the Shire ruling has already been cited against the FTC in at least four other pending….. To continue reading this legal news please click Read full information...
Prematurely Terminating Use of Vivitrol May Increase Chance of Overdose
Prematurely Terminating Use of Vivitrol May Increase Chance of Overdose The post Prematurely Terminating Use of Vivitrol May Increase Chance of Overdose appeared first on Legal Reader... To continue reading this legal news please click Read full information...
Posted in Products Liability
Tagged Chance, increase, Overdose, Prematurely, Terminating, Vivitrol
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How Safe is the Safe Harbor?
By Sara W. Koblitz — As the breadth of the “patent safe harbor” continues to expand under the Federal Circuit’s growing body of relevant case law, some patent holders are looking to the Supreme Court to push back. In a Petition for Certiorari filed last week in Classen Immunotherapies v. Elan Pharmaceuticals (and sent to us by Alex MacCormick over at Center Lane, LLC), patent-holders challenge the District Court’s (as affirmed by the Federal Circuit) interpretation of routine and non-routine. Codified in 35 U.S.C. § 271(e), the safe harbor exempts drug development and approval from patent infringement: It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary….. To continue reading this legal news please click Read full information...
Does the Agency Need Statutorily Imposed Incentives for Regulatory Compliance Matters?
By Mark I. Schwartz — Last year, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) to revise and extend the user fee programs for drugs, medical devices and biosimilar biological products. Section 902 of FDARA requires FDA to publicly report, annually, information related to inspections of facilities necessary for approval of these medical products. Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous calendar year. Such information shall include the….. To continue reading this legal news please click Read full information...
Posted in Products Liability
Tagged agency, Compliance, imposed, incentives, Matters, need, Regulatory, Statutorily
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YouTube is Violating Children’s Privacy Law, Complaint Will Allege
YouTube is Violating Children' Privacy Law, Complaint Will Allege The post YouTube is Violating Children’s Privacy Law, Complaint Will Allege appeared first on Legal Reader... To continue reading this legal news please click Read full information...
Posted in Products Liability
Tagged allege, Childrens, Complaint, Privacy, Violating, YouTube
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