Industry Roundup: Supplement GMPs, Walgreens Recall, Healthy Children Study, Homeopathic Comments, Drug Claims
This article was originally published in The Tan Sheet
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.
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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.
Loss of exclusivity and other competitive pressures will continue to offset J&J’s pharmaceutical growth as its former blockbusters accumulate in ex-growth "other" categories. Can the pipeline take up the slack?