In Brief: Acetaminophen Warnings, OTC HSA Bill, Durbin’s Supplement Reg Bill
FDA adds acetaminophen warnings; CHPA suggests 4-aminophenol standard; OTC HSA bill in House; supplement registration bill reintroduced; FSMA user fees still on hold; more scrutiny of energy drinks; and Public Citizen pans OTC Oxytrol.
Learn what's happening at the US FDA. On the go.
More from Distribution/Supply Chain
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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
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A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
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The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
More from Compliance
HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments
• ByJoint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
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Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
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The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
