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…add to the “others” category – for better or for worse – competitors, regulators, self-regulators, the Center for Science in the Public Interest, and plaintiffs’ lawyers. The database currently contains…
…Anne K. Walsh (awalsh@hpm.com). Candidates must be members of the DC Bar or eligible to waive in. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer….
…scheduled for Friday, October 8, 12:00 p.m. – 1:30 p.m. For those last minute stragglers, there’s still time to register at the event website. (Registration will close 3 hours before…
…As with the company’s Complaint, Novartis argues in its TRO/PI motion that FDA’s decision to approve ANDA No. 78-278 is inconsistent with a March 15, 2010 FDA citizen petition decision. …
…focus of global regulators. With the latest updates to the global standard for medical device quality management systems and the proposed new EU Medical Device Regulations, device manufacturers, service providers,…
…provide adequate information regarding those data to allow critique of them. Banner Health v. Price, 867 F.3d 1323, 1335 (D.C. Cir. 2017); United States Lines, Inc. v. Federal Maritime Com.,…
…authority of section 404 of the Federal Food, Drug, and Cosmetic Act, after a New York banker was killed by botulism in a can of Bon Vivant vichyssoise – an…
…in 1982 Federal Register notices. According to FDA, since 1969, when FDA first implemented an adverse event reporting system, and as of 2005, the Agency “has received more than 400…
…regulation is preferred; strong research and writing skills are required. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and…
…a detailed understanding of FDA and the regulatory process. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and a…
…quality metrics, as discussed in prior blogposts (here, here, and here). Moreover, FDA encourages industry to aim for continuous improvement in manufacturing, laboratory, and quality systems. So, back to corn…
…for, when interviewing women whose narratives began to stray, telling them, “Just the facts, ma’am.” * Scott and Jasmin are legal assistants who provided research assistance for this blog post….
…inflammatory complications associated with COVID-19. Vered Kaplan, CEO of Orgenesis, a global biotech company, which is unlocking the potential of cell and gene therapy including anti-viral technologies relevant for COVID-19…
…Act, Proposed SOM Rule, the “ORUSC,” and Distribution Trends (3:20 – 4:00 p.m.) Larry K. Houck and Kenneth Weinstein To RSVP for this program, please email Amy Vasvary at avasvary@hpm.com…
…Application for accreditation of this program for Continuing Legal Education (CLE) in California, Massachusetts, New Jersey, and New York is currently pending. For questions, please contact Reiko Tate (reiko.tate@dechert.com). …