The discovery of nitrosamine contamination in prescription drugs continued to command regulatory attention in recent weeks.
It prompted the US Food and Drug Administration to explain why it tested and found nitrosamine impurities at lower levels...
Quality Lowdown: FDA Defends Nitrosamine Testing Methods While US, EU Enforcement Continues
Listen to this article
The crisis of nitrosamine contamination in prescription drug products continues to roil the world’s health authorities and prompts debate on the different approaches used to measure these impurities. Meanwhile, an Austrian firm gets inspected despite the pandemic and yet another homeopathic firm gets an FDA warning letter.
Learn what's happening at the US FDA. On the go.
More from Manufacturing
• By
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.
• By
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
• By
Joint 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.
• By
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
• By
Joint 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.
• By
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
• By
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.