Industry Roundup: NBTY China JV, Bucks For Bugs
This article was originally published in The Tan Sheet
Nellson consolidates in Anaheim; Plant Based Food group opens; Bots builds BioPharmx business; and more news in brief.
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The firm owned since 2010 by a Carlyle Group holding company opts for a name that encompasses its largest brand, which also had been its name until the previous management chose the name NBTY in 1995.
Lucky STAR: FDA’s eSTAR Pilot Aims To Make 510(k) Process Smoother With Submission Template For Device Makers
Nine manufacturers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.
W3ll People is expected to add a relatively modest $7m to e.l.f. Beauty’s fiscal 2021 top line, but the brand has “major white space” opportunities, including at Target, e.l.f.’s longest-standing customer. Further, its plant-based product line includes 40 “EWG Verified” products, reflecting expertise e.l.f. is eager to tap.