‘Unlawful Marketing’ Doesn't Establish Dietary Ingredients' Use Before Drug Approval Or Study
FDA explains thinking in a letter to Inner Mongolia Kingdomway Pharmaceutical after rejecting Chinese firm’s NDI notification for N-acetyl-L-cystein. Prior to its investigation as a drug, NMN wasn’t used in supplements available in US, “except unlawfully without an NDI notification.”
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Bayer Relates Feeling ‘Sexy’ To Quick Relief For Allergies In Astepro Allergy Ad Campaign
Campaign featuring actress Meghann Fahy says "allergy sufferers can relieve their allergy symptoms and be more spontaneous in their romantic pursuits.” Ads launch two months after FDA granted tentative approval for two ANDAs for generic equivalents, indicating approval could come pending resolution of patent litigation.
US Infant Formula Supply Chain Strategy Delivered
FDA immediate actions include ensuring providers know they’re required to develop redundancy risk management plans, enhancing inspections of manufacturers, including by expanding and improving training for investigators, and expediting reviews of premarket submissions for new products.
FDA Report On US Formula Supply Doesn’t Stop Criticism From Congress, Former Food Policy Chief
On same day agency published strategy for ensuring formula supply, House Oversight Committee subcommittee members made clear they’re not convinced FDA could prevent repeat of 2022 shortage. Recently resigned FDA food policy chief also has doubts.