Drug Recalls Soared Again in 2013, Driven by Contamination
FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.
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More from Manufacturing
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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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The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
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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The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
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.
