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…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…
…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…
…of the proposed regulation would extend beyond just carcinogenity and reproductive toxicity – i.e., Proposition 65 hazard traits – to also include neurotoxicity, endocrine toxicity, epigenetic toxicity, totoxicity, phytotoxicity and…
…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…
…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…
…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…
…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…
…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….
…NDA that support the inclusion of each statement in the labeling. 21 CFR 314.50. Needless to say, teams of professionals, including clinicians, statisticians, pharmacists, clinical pharmacologists, and commercialization and reimbursement…
…Kroger Co., C&S Wholesale Grocers, Inc., Associated Wholesale Grocers, Inc., McLane Co, Inc., Procter & Gamble Co., Tyson Foods, Inc., and Kraft Heinz Co. It is possible the FTC will…
…culture is collaborative, the work environment is flexible, and the subject matter is intellectually stimulating. If you want to join our team, please send your resume to Anne Walsh, awalsh@hpm.com….
By Kurt R. Karst – On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th…