FDA Talks Up Continuous Manufacturing, Offers Assistance
It is time for drug makers to embrace continuous manufacturing methods, CDER Director Janet Woodcock and other FDA officials have been emphasizing in recent months. Now the agency is offering additional support to help manufacturers overcome regulatory barriers, real or perceived, and wean themselves from batch processes.
Learn what's happening at the US FDA. On the go.
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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.
