CDER head is worried FDA won’t be able to sustain gains the agency made on drug shortages and supply chain work as big CARES Act boost set to run out this year, yet it didn’t ask Congress for new taxpayer funding in the fiscal year 2024 budget request.
The US Food and Drug Administration is concerned about an upcoming falloff in funding for drug shortage work as it faces a rise in shortages due to an increasingly complex supply chain, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said.
CDER has spent $10m of the $14m Congress gave it to support drug shortages work in the 2020 COVID-19 pandemic...
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.
