US FDA amends cGMP regulations to prevent drug labelling errors
This article was originally published in SRA
The US Food and Drug Administration has issued a final rule that will allow drug manufacturers to use a broader range of "error prevention" and "labelling control" techniques than are permitted under the agency's current good manufacturing practice regulations for human and veterinary drug products1.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.