Malcolm Spicer
US Consumer Health Managing Editor
Latest From Malcolm Spicer
US FDA Supplement Facility Inspection Numbers Back To Typical Along With GMP Problems Found
Supplement facility GMP inspections by FDA in 2022 along with the frequency of form 483s sent to firms following inspections return to roughly pre-pandemic annual numbers after dipping during 2020 and 2021.
US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too
FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.
US FDA’s Infant Formula Regulatory Authority Doesn’t Reach ‘All That Needs To Be Fixed’
“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.
Errors Coughed Up For Dextromethorphan, Guaifenesin In US FDA Electronic Registrations
Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.
US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE
Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.
Empowered By Evidence Debuts Lists Of Natural Health Ingredients Meeting Its Standards
Global nonprofit supporting evidence-based product development in natural health sector and American Botanical Council announce database intended to help consumers, researchers and health care professionals make natural product choices based on specific scientific and clinical evidence.