Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.
Valisure LLC, a pharmacy venture launched in 2015 to protect patients by testing medicine before dispensing it, has come under fire from the US Food and Drug Administration for failing to comply with good manufacturing practices.
A recent untitled letter to the firm sends a clear message: if anyone wants to protect patients from poorly made...
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.
