Sixteen US states have issued executive orders or other mandatory directives to preserve hydroxychloroquine and chloroquine for non-COVID-19 patients, while 26 states have issued similar voluntary guidance. The federal government is reserving some of the strategic national stockpile supply of the drugs for non-COVID-19, as private players in the supply chain also join in the efforts to balance on-label use with COVID-related demand.
States and the federal government are taking unusual steps to help ensure on-label access to hydroxychloroquine and chloroquine following a shortage that occurred after US President Donald Trump hyped the potential of the drugs for COVID-19, leading to a dramatic increase in demand even as trials in coronavirus patients are still ongoing.
Sixteen states have issued rules, executive orders or other mandatory directives that are designed to help preserve stock of the...
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.
