Letter of authorization for COVID-19 therapeutic made at troubled Lilly plant requires independent third-party oversight.
The US Food and Drug Administration has found a way to authorize emergency use of an Eli Lilly and Company COVID-19 therapeutic even though the facility that manufactures the drug substance is in trouble with the agency over data integrity issues.
The Defense Department and the FDA’s parent agency, the Health and Human Service Department, agreed on 28 October to buy...
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.
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.
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.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
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.
