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Regulation/Legislation (Wellness)

Set Alert for Regulation {Wellness}

Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

Wellness Advertising, Marketing & Sales Business Strategies

Latest OTC Homeopathic Firm Using Rx Indications Also A Repeat GMP Offender

FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.

FDA Regulation OTC Drugs

Regulation

Set Alert for Regulation {Wellness}

Latest From Wellness & Regulation

Health And Wellness Trademark Review 3 December, 2019

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Trademarks OTC Drugs

FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.
Dietary Supplements Manufacturing

HBW Executive Decisions: HELP Endorses Hahn, Industry Award For AHPA's McGuffin, CHPA, Herbalife Hires

CHPA adds Allgaier to head development, relations; Vetere joins Herbalife as VP, CIO; Hahn's FDA commissioner nomination clears HELP committee; and AHPA's McGuffin recognized as 2019 Industry Leader.

Appointments OTC Drugs
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