Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.
Drug shortage staff at the US Food and Drug Administration are asking industry to notify them of demand spikes, even though it’s not required, so supply problems can be prevented.
Valerie Jensen, associate director of the FDA drug shortage staff, said on 1 December during an Alliance for a Stronger...
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.
