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Sigh. We’ve been dragged (kicking and screaming) into the 21st Century. So, we’ve put down our quill pens and are now twittering at www.twitter.com/fdalawblog. Many of our “tweets” will link…
…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…
…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….
…pledged that the frequency of these inspections would increase. The GMP by the Sea conference is a regular conference (it was held annually until COVID hit) sponsored by PharmaConference (www.pharmaconference.com)….
…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…
…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…
…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]…
…a product marketed as a dietary supplement; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hua-da-trading-inc-664359-12202023); Botanical Be of El Paso, Texas (“Kuka Flex Forte” and “Reumo Flex,” marketed as dietary supplements, contain diclofenac; Warning Letter; and com,…
…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…
…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…
…evaluation, participants will be asked to use the database and provide feedback. Participation can be in person in Washington, D.C. or online. Contact Kristina Schall at kristina.schall@opinionstrategies.com to sign up….
…whether supply chain disruptions are leading to specific bottlenecks, shortages, anti-competitive practices, or contributing to rising consumer prices.” The recent section 6(b) orders were sent to Walmart Inc., Amazon.com, Inc.,…
…data for product components developed in a complex global supply chain. This requirement will be expanded exponentially once California’s Department of the Office of Health Hazard Assessment (“OEHHA”) issues its…
…ideal candidate will have experience working at FDA or with a medical device company, and prior big law firm experience is helpful. Compensation is competitive and commensurate with experience. HP&M…
…at FDA or by assisting companies develop product development strategy or navigate the regulatory process. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M…