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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

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.

Ad Campaigns Legal Issues

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 Supply Chain

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.

FDA Supply Chain

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.

Prescription To OTC Switch Approvals

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

FDA Approvals

‘Recipe For Disaster’ In Supplement Manufacturing? US DoJ Attorney Cooks Up Likely Causes

"You end up with a recipe for maybe there's adulterants in the product. Maybe the product wasn't manufactured according to the spec, so it's misbranded. Worse, there could be adulterants. In some of those ingredients, there's a lot of potential failures,” says Patrick Runkle, senior litigation counsel at DoJ Consumer Protection Branch, during FDL conference.

Supply Chain Dietary Supplements
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