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…such as roadside stands, farmers’ markets, Community Supported Agriculture (CSA) programs, and other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online…
By Jay W. Cormier & Alan M. Kirschenbaum – In an advisory opinion posted on Monday, July 28, 2014, the Office of the Inspector General of the Department of Health…
By Alexander J. Varond & James E. Valentine – On May 20, 2014, Hyman, Phelps & McNamara, P.C.’s Frank J. Sasinowski appeared on a panel before the House Energy and…
…last month, the POM defendants have appealed the Commission’s decision in federal court. For now, however, the Commission decision – including its findings on scientific literature – stands. The recent…
…24, 2018, FDA sent an official request for information to JUUL Labs, requesting the company submit information, such as documents related to product marketing; research on the health, toxicological, behavioral…
…a disease or condition for which the treatment, control, or prevention is not adequately addressed by available therapy or, if a therapy exists, the new drug is expected to provide…
…tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the guidances “will be made final as soon as possible after public comment, and will be…
…pharmacologic science as a basis for regulation affecting human safety and health, and the environment. The current ISRTP Council President is Hyman, Phelps & McNamara, P.C.’s Diane B. McColl. [http://www.hpm.com/vattorney.cfm?RID=27]…
…Application, Abbreviated New Drug Application, or Biologics License Application. These are called Pre-Approval Inspections, and, when COVID difficulties would otherwise delay inspections leading to drug approvals, numerous applicants have struggled…
…where the company removes or edits negative posts about its products and adds positive commentary. The company, by doing so, has exerted control over the UGC. However, FDA clarified that…
…biodynamic farming, pasture-feeding of livestock, community-supported farms, honest and informative labeling, prepared parenting and nurturing therapies.” The Foundation has also been a staunch advocate www.realmilk.com for increased availability and consumption…
…outside counsel, distinguished in-house counsel and compliance officers, as well as 9 government enforcers and regulators. They will help those in attendance: REASSESS compliance programs as a result of the…
…which sells green tea at www.teaforhealth.com, submitted its health claim petition to FDA on January 27, 2004. The company claimed that its green tea QHC was based upon two separate…
…in 2019 that may shape future FDA regulation. We hope this report proves useful and interesting to you. For more information about HP&M, please go to our website at www.hpm.com….
…6 months of pediatric exclusivity (until June 2, 2013). FDA, following the explanation provided in the Agency’s March 27, 2012 Letter Decision, [http://www.hpm.com/pdf/blog/SEROQUEL%20-%20FDA%20Letter%20Decision%203-27-2012.pdf] primarily argued that the scope of 3-year…