Many US Food and Drug Administration drug warning letters in 2022 raised concerns about inadequate sterility assurance, particularly for water systems and traditional open clean rooms.
US Warnings Show Focus On Sterility Risks From Water Systems Following OTC Drug Firm's Problems
A B. cepacia contamination recurrence led the US FDA to double down on sterility assurance of water systems in 2022, a trend likely to continue, Part 7 of our series finds. Open cleanroom contamination continued to drive warning letters as Annex 1 policy revision adds incentives to separate workers from injectable drug products with access barriers or isolators.
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FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
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UK industry association is offering online courses on subjects ranging from UK medicines regulations basics to deep dives on complex topics such as CBD.
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Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”
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New Jersey Assembly passed bill amended to expand extensively in defining which products, or ingredients, would be subject to a ban on sales to consumers younger than 18.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”