Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
Appropriation Committee members target $5m for FDA's CBD policy work and suggest the agency enforce against noncompliant firms in their report accompanying legislation proposing the agency’s fiscal 2021 budget.
FDA’s second report to Congress on oversight of CBD market includes results from studies of whether products are mislabeled or adulterated, but also indicates throughout that more data are needed on safety of hemp-derived CBD ingredients used in myriad consumer health, cosmetic and food products already available.
FDA approval for Perrigo's ANDA for two loperamide products listed as tablets follows CBE label changes Johnson & Johnson and BionPharma made for their branded OTCs containing the ingredient in 2019.
US OTC Decisions In June: Third Tentative Approval For Omeprazole Delayed Release ANDA, More Esomeprazole PPI Final Approvals
FDA told P&L Development, as it had with Aurobindo Pharma and Hetero Drugs, that its ANDA for a generic of Prilosec OTC delayed release is tentatively approved because exclusivity has not expired for Perrigo's first-approved generic of the PPI.
Appropriations subcommittee notes the funding in summary of its draft budget bill. Language on FDA’s development of CBD regulatory framework will be included in panel’s report to be released 24 hours before full committee’s markup.
In update to notifications about hand sanitizer labeled as containing ethyl alcohol but contaminated with methanol, FDA says some distributors are voluntarily recalling products. But manufacturer Eskbiochem didn't respond to request to recall its products marketed in US under multiple brands.