Food and Agriculture
Seth counsels on matters related to human food, feed and dietary supplements, including providing advice tailored to the dairy industry and ethanol producers. Seth leads Michael Best’s food safety panel, which assists clients with generally recognized as safe (GRAS) self-certification, among other reviews. The FDA Regulatory group provides guidance on everything from food labeling and advertising to petitions for direct and indirect food additives.
Seth handles a range of pre- and post-market regulatory issues involving medical devices, from crafting regulatory strategies for device development to the regulation of both commercial and medical electronic products. Work includes the preparation and prosecution of premarket notifications [510(k)s] and premarket approvals (PMAs) and development of quality systems compliant with FDA’s Quality System Regulation [21 C.F.R. part 820].
Mobile Medical Apps and Other Medical Software
Medical software presents unique regulatory challenges requiring compliance with highly technical requirements. Seth has successfully obtained marketing authorization for numerous telemedicine and other medical software applications. In particular, Seth has helped clients with preparing the detailed submissions disclosing important aspects of the software design control process.
Drugs and Biologics
Seth has counseled brand and generic manufacturers and secondary manufacturers on a full scope of Hatch-Waxman matters, including exclusivity periods for brand and generic drugs and the citizens petition process. Seth also helps with other technical requirements, including drug registration and listing, compliance with current good manufacturing practice (cGMP) requirements, and preparing detailed responses during premarket reviews of new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Seth has long counseled clients in the tobacco industry on compliance with the Family Smoking Prevention and Tobacco Control Act, and currently advises manufacturers, retailers and distributors on product approval, marketing and sales practices. His counseling includes advice to cigar and electronic cigarette manufacturers on FDA regulations and strategies for bringing those tobacco products through the premarket application process, preparing premarket tobacco product applications (PMTAs) and substantial equivalence reports (SE Reports), among other submissions.