FDA Sending More Drug GMP Warning Letters to Foreign Sites
FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.
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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.
