In addition to AZX Sport lip balms and hand sanitizers, other topical consumer drugs often considered personal care or cosmetic products outside the US were added in the latest update to FDA's list of import alerts for "detention without physical examination of drugs from firms which have not met drug GMPs."
Canadian firm Aztex Enterprises Ltd. was blocked from exporting its lip balms and hand sanitizers to the US after FDA determined it was using ingredients supplied by a second Canadian firm the agency already had on import alert for good manufacturing practices problems.
In a separate import alert for products deemed unapproved drugs due to the label claims, FDA also recently blocked imports...
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.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.
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.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
