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…to determine, on a case-by-case basis, what constitutes a “reasonable probability that the use of, or exposure to, [the] article of food will cause serious adverse health consequences or death…
…clearance or approval, and made false statements to government officials. The indictment alleges that Synthes, an orthopedic device manufacturer, purchased Norian Corporation in 1999, the manufacturer of Norian SRS, a…
…of food will cause serious adverse health consequences or death to humans or animals.” Pursuant to FDAAA, FDA was to establish the Registry by September 27, 2008. On May 27,…
…way of background, the USDA, in its effort to stem the increase in SE outbreaks associated with consumption of table eggs (i.e., raw eggs sold in their shells), issued regulations…
…detained (e.g., cereal preparations, snack foods, and candy specialties). On November 13, 2008, FDA published a Federal Register notice requesting comment on its October 3, 2008 “Interim Safety and Risk Assessment…
On June 23, 2008, Representative William Delahunt (D-MA) introduced, and the U.S. House of Representatives quickly passed by voice vote, H.R. 6344 – the Responsive Government Act of 2008. The…
…2009. Meanwhile, FDA requests comments concerning the Registry provision in FDAAA. Specifically FDA asks for comment on: “What obstacles, if any, . . . responsible parties anticipate in complying with…
…Senate. The already crowded field became a little more congested when Representative Rosa DeLauro (D-CT), chairwoman of the House Appropriations Committee, Subcommittee on Agriculture, Rural Development, Food and Drug Administration…
…Subpart J, require persons that manufacture, process, pack, hold, transport, distribute, receive, or import food under FDA’s jurisdiction to maintain records that identify the immediate previous sources and immediate subsequent…
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas…
…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…
…Kong 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)….
…how to deal with the government’s demands for information, directed to the company, its current employees, and even former employees, while protecting the company’s interests. The webinar will feature HP&M…
…are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com)….
Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit’s recent and long-awaited decision in United States…