Industry Roundup: Supplement GMPs, Walgreens Recall, Healthy Children Study, Homeopathic Comments, Drug Claims
This article was originally published in The Tan Sheet
Executive Summary
Botanicals firm argues GMP intent; Walgreens multivitamin missing child-resistant capsWyeth Nutrition supports NIH healthy children study; homeopathic regulatory evaluation comment period extended; Vitamin Shoppe adds Beardall; and more news in brief.
You may also be interested in...
Homeopathic Regulatory Evaluation Stocked With FDA Concerns, Industry Answers
The industry wants FDA to consider that a fraction of poison control reports are for homeopathics compared to other drugs and the agency’s current enforcement authorities maintain compliance in manufacturing and marketing the products. FDA is considering whether to maintain its policy that recognizes an ingredient’s inclusion in the HPUS monograph as pre-market approval.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.