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…the scope of interstate commerce since Regenerative obtains “components” to manipulate the stem cells from outside of the state. Second, and most amazingly, the Government argues that interstate commerce is…
…FTC case law beyond this order – defines “competent and reliable scientific evidence” specifically based on the “expertise of professionals in the relevant area.” (The Bayer 2007 order defines “competent…
…sufficient showing at this juncture to support its application for an Order to Show Cause” (Order at 1), is not clear. However, we expect that the company may well engage…
…FDA proposed that, to be a valid prescription order for a compounded drug product, the prescription order needed to state clearly that it is for a compounded drug and necessary…
…the Order and Injunction. Novo promptly appealed the decision to the Federal Circuit, where the company is seeking a stay of the district court’s Order and Injunction. The district court’s…
…and a demonstrated interest in food and drug law and regulation. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript,…
…practices, 2) conduct audits of suppliers to confirm lack of such involvement, 3) require direct suppliers to certify that materials used in products are complying with laws concerning slavery and…
…27 6 53 India 9 31 6 46 United States 774 722 99 1595 2011 Country NAI VAI OAI Total China 32 41 1 74 India 37 59 6 102…
…competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Deborah Livornese (dlivornese@hpm.com). Candidates must be members of…
…liability risks Speakers: David B. Clissold, Director, Hyman, Phelps & McNamara, P.C. Hope S. Freiwald, Partner, Complex Commercial Litigation/Life Sciences, Dechert LLP David A. Kotler, Partner, White Collar and Securities…
…law at the U.S. Food and Drug Administration (FDA), a law firm, or an FDA-regulated company. Candidates must have excellent academic credentials and strong communication and writing skills. Candidates should…
…Device Promotion on Social Media: Regulatory Considerations and Best Practices.” Social Media is increasingly being adopted as a tool for promoting medical devices (see our recent post here). However, use…
…on drugs with potential safety risks. FDA’s action comes on the heels of an article on CNN.com and an editorial in the Wall Street Journal critical of the Agency’s handling…
A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in…
…domestic and foreign manufacturers. REMINDER: Register for HPM’s free webinar “The Evolution and Resurgence of Strict Liability Criminal Prosecutions Under the Park Doctrine” on October 8th. (link to registration: http://hpmwebinar.eventbrite.com/)…